Cytarabine Accord
Cytarabine 20 mg/ml – Solution for Injection or Infusion
Cytarabine Accord contains the active substance cytarabine at a concentration of 20 mg/ml. It is a potent chemotherapy drug belonging to the antimetabolite class of cytostatic agents. Used to treat acute leukemias in both adults and children, Cytarabine Accord can be administered intravenously, subcutaneously, intramuscularly, or intrathecally under specialist supervision in hospital settings. Cytarabine works by disrupting DNA synthesis in rapidly dividing cancer cells, ultimately leading to their destruction. This comprehensive guide covers its uses, dosage, side effects, drug interactions, and storage requirements.
Quick Facts
Key Takeaways
- Cytarabine Accord is a chemotherapy drug used primarily for acute leukemias and meningeal leukemia, both for inducing remission and for maintenance therapy.
- It is administered only in hospital settings by specialized healthcare professionals experienced in cancer treatment, via intravenous, subcutaneous, intramuscular, or intrathecal routes.
- Bone marrow suppression is the most significant side effect, requiring regular blood monitoring throughout treatment; blood cell counts may continue to decline for up to one week after stopping treatment.
- Both men and women must use effective contraception during treatment—women for at least 6 months and men for at least 3 months after the last dose—due to the risk of birth defects.
- Cytarabine syndrome—fever, bone and muscle pain, conjunctivitis, and malaise occurring 6–12 hours after treatment—is a common but treatable side effect that can be managed with corticosteroids.
What Is Cytarabine Accord and What Is It Used For?
Quick Answer: Cytarabine Accord is a chemotherapy medication containing cytarabine (20 mg/ml), an antimetabolite that belongs to the pyrimidine analogue group of cytostatic drugs. It is used to treat acute leukemias (cancers of the blood) in both adults and children, and to prevent or treat meningeal leukemia—leukemia affecting the membranes surrounding the brain and spinal cord.
Cytarabine, also known as cytosine arabinoside (Ara-C), is one of the cornerstone drugs in the treatment of acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). First introduced into clinical practice in the 1960s, it has remained a fundamental component of leukemia treatment protocols for over five decades and continues to be an essential element of modern combination chemotherapy regimens. International guidelines from the National Comprehensive Cancer Network (NCCN), the European LeukemiaNet (ELN), and the European Society for Medical Oncology (ESMO) all include cytarabine as a central component in the treatment of acute leukemias.
The drug belongs to a group of medicines called cytostatic agents (also known as antineoplastic agents or chemotherapy drugs). These medicines work by interfering with the growth and division of cancer cells, ultimately leading to their destruction. Specifically, cytarabine acts as a nucleoside analogue that mimics the natural building blocks of DNA. Once inside the cell, it is converted to its active form, cytarabine triphosphate (ara-CTP), which competes with the normal nucleotide deoxycytidine triphosphate (dCTP) for incorporation into DNA during the S-phase of the cell division cycle. This incorporation disrupts DNA synthesis, causes chain termination, and triggers cell death through a process known as apoptosis.
Cytarabine Accord is specifically formulated at a concentration of 20 mg/ml, making it suitable for a range of administration routes including intravenous (IV), subcutaneous (SC), intramuscular (IM), and intrathecal (IT) injection. This versatility is particularly important in clinical practice, as intrathecal administration allows the drug to reach the central nervous system directly—an area that is otherwise difficult to penetrate with many chemotherapy agents due to the blood-brain barrier.
Cytarabine Accord is used for several therapeutic purposes:
- Induction of remission: This is the initial, intensive phase of treatment designed to rapidly reduce the burden of leukemia cells in the body. When successful, the balance of cells in the blood and bone marrow returns toward normal, and the patient enters a state known as remission. Standard induction therapy typically involves higher doses of cytarabine in combination with anthracyclines such as daunorubicin or idarubicin (the widely used “7+3” regimen).
- Maintenance therapy: Once remission has been achieved, maintenance treatment uses lower doses of cytarabine to prolong the remission period and prevent relapse. Maintenance therapy is generally less intensive and better tolerated than induction treatment, and it may be continued for months or even years depending on the treatment protocol.
- Prevention and treatment of meningeal leukemia: Leukemia cells can spread to the cerebrospinal fluid (CSF) and the membranes (meninges) surrounding the brain and spinal cord. Intrathecal cytarabine is injected directly into the spinal fluid to prevent or treat this form of disease involvement.
In addition to these primary indications, cytarabine may be used as part of consolidation therapy (intermediate-intensity treatment after remission is achieved) and in high-dose protocols for certain types of leukemia. The World Health Organization (WHO) includes cytarabine on its Model List of Essential Medicines, recognizing it as an indispensable treatment for acute leukemias worldwide.
Cytarabine Accord should only be administered under the supervision of a physician experienced in the use of cancer chemotherapy drugs. Treatment is always given in a hospital or specialized clinical setting where appropriate monitoring and supportive care are available. The prescribing physician will determine the most appropriate dose, route, and schedule based on the individual patient’s condition.
What Should You Know Before Taking Cytarabine Accord?
Quick Answer: Before starting cytarabine treatment, your doctor must assess your overall health, blood counts, liver and kidney function, and vaccination history. Absolute contraindications include known allergy to cytarabine, severely low blood counts from non-cancerous causes, severe neurological damage from prior chemotherapy or radiation, and pregnancy.
Before beginning treatment with Cytarabine Accord, your healthcare team will conduct a thorough evaluation to ensure the drug is safe and appropriate for you. This assessment is critical because cytarabine is a potent medication with significant effects on the body, particularly the bone marrow and immune system. Understanding the contraindications, warnings, and precautions is essential for safe and effective treatment.
Contraindications
You must not receive Cytarabine Accord if any of the following apply:
- Allergy to cytarabine or any other ingredient: If you have a known hypersensitivity to cytarabine or to any of the excipients in the formulation (sodium chloride, sodium hydroxide, hydrochloric acid, water for injections), this medication must not be used. Allergic reactions can range from mild skin rash to life-threatening anaphylaxis.
- Very low blood counts from non-cancerous causes: If your blood cell counts are severely reduced due to a condition other than cancer (such as aplastic anemia or myelodysplastic syndrome not requiring cytarabine), this medication should generally not be administered unless the treating physician determines the potential benefit outweighs the risk, as it would further suppress blood cell production.
- Previous severe neurological damage: If you have experienced severe difficulty coordinating movements (cerebellar toxicity or encephalopathy) after radiation therapy or treatment with other chemotherapy drugs such as methotrexate, cytarabine should not be used due to the risk of worsening or irreversible neurological damage.
- Pregnancy: Cytarabine must not be used during pregnancy. The drug is known to be teratogenic (capable of causing birth defects) and embryotoxic in both animal studies and human case reports.
Warnings and Precautions
Special caution is required in the following situations. Talk to your doctor, pharmacist, or nurse before receiving Cytarabine Accord:
- Bone marrow suppression: Cytarabine profoundly suppresses the production of blood cells in the bone marrow. This is the most significant and dose-limiting side effect. It can make you highly susceptible to infections (due to low white blood cells) and bleeding (due to low platelets). Your blood cell counts may continue to fall for up to one week after treatment ends. Your doctor will perform regular blood tests and may examine your bone marrow as needed to guide treatment decisions.
- Liver function: If your liver is not functioning well before treatment begins, cytarabine should only be given under close medical supervision. The liver plays an important role in the metabolism and detoxification of the drug, and impaired liver function may increase the risk of adverse effects.
- Previous radiation therapy: Patients who have received radiation therapy may be at increased risk of certain side effects, particularly when cytarabine is administered at high doses or in combination with other neurotoxic agents.
- Granulocyte transfusions: If you are receiving transfusions of certain types of white blood cells (granulocytes), special monitoring may be required due to the potential for interactions.
- Dialysis patients: If you are undergoing or have recently undergone dialysis, your doctor may need to adjust the timing of cytarabine administration. Dialysis can reduce the effectiveness of the drug by removing it from the bloodstream before it has had time to act.
During treatment, your healthcare team will perform regular monitoring including:
- Complete blood counts: Regular blood tests to monitor white blood cells, red blood cells, and platelets.
- Liver and kidney function tests: Blood tests to ensure cytarabine is not adversely affecting organ function.
- Neurological assessment: Tests to check nerve function, particularly important during high-dose treatment.
- Uric acid levels: As cancer cells are destroyed, uric acid is released into the bloodstream (hyperuricemia). Your doctor may prescribe medication such as allopurinol or rasburicase to control these levels and protect the kidneys.
During treatment with cytarabine, you should not be vaccinated with live or attenuated (weakened) vaccines. Your immune system will be significantly suppressed, which means live vaccines could cause the very infection they are designed to prevent. Even inactivated (killed) vaccines may not produce an adequate immune response during treatment. Consult your doctor before receiving any vaccination.
Other Medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including:
- Medicines containing digoxin or beta-acetyldigoxin (used for heart conditions)
- Gentamicin (an antibiotic for bacterial infections)
- 5-flucytosine (an antifungal medication)
- Medicines containing cyclophosphamide, vincristine, and prednisone (used in cancer treatment programs)
- Other immunosuppressive medicines (such as azathioprine or mercaptopurine)
- Methotrexate (used for various cancers and inflammatory conditions)
- Idarubicin (used for leukemia and breast cancer treatment)
Pregnancy and Breastfeeding
Cytarabine Accord must not be used during pregnancy as it can cause severe birth defects. Both male and female patients must use effective contraception during treatment. Women of childbearing age should use effective contraception during treatment and for at least 6 months after the last dose. Male patients must use effective contraception during treatment and for at least 3 months after the last dose. Breastfeeding must be discontinued before starting treatment, as the drug may be harmful to nursing infants.
Cytarabine has been demonstrated to be teratogenic and embryotoxic in both animal studies and human case reports. There is a clear and well-documented risk of fetal harm when administered during pregnancy. For this reason, pregnancy is an absolute contraindication to treatment. If you suspect you are pregnant, inform your doctor immediately.
Cytarabine may also affect fertility. In women, it can suppress the menstrual cycle and lead to amenorrhea (absence of menstrual periods). In men, it can suppress sperm production (azoospermia). These effects may be temporary or permanent. Patients who wish to have children in the future should discuss fertility preservation options with their healthcare team before starting treatment.
Driving and Using Machines
Cytarabine itself has no direct effect on the ability to drive or use machines. However, cancer treatment in general can cause side effects such as fatigue, dizziness, drowsiness, confusion, and visual disturbances that may impair your ability to drive or operate machinery safely. You are responsible for assessing whether you are fit to perform these activities. If you experience any symptoms that affect your alertness or coordination, do not drive or use machines.
Sodium Content
Cytarabine Accord contains less than 1 mmol sodium (23 mg) per 5 ml, meaning it is essentially sodium-free. This is relevant for patients on a sodium-restricted diet.
How Does Cytarabine Accord Interact with Other Drugs?
Quick Answer: Cytarabine can interact with several other medications, potentially increasing toxicity or reducing the effectiveness of either drug. Notable interactions include 5-flucytosine (reduced antifungal efficacy), cardiac glycosides such as digoxin (reduced absorption), gentamicin (additive toxicity), and methotrexate (increased neurological risk, particularly in children).
Drug interactions are an important consideration when using Cytarabine Accord, as patients undergoing chemotherapy often receive multiple medications for supportive care, infection prevention, and treatment of concurrent conditions. Cytarabine is frequently used in combination with other chemotherapy agents as part of established treatment protocols, and the healthcare team carefully manages these combinations to balance effectiveness against cumulative toxicities.
Always inform your healthcare team about all medications you are currently taking, have recently taken, or may be planning to take, including over-the-counter drugs, supplements, and herbal remedies. Some drug interactions may require dose adjustments, alternative medications, or enhanced monitoring.
Major Interactions
The following drug interactions are considered clinically significant and require careful management:
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| 5-Flucytosine | Cytarabine may reduce the effectiveness of 5-flucytosine by competing for the same intracellular activation pathway | Monitor antifungal response closely; alternative antifungal therapy may be needed |
| Digoxin / Beta-acetyldigoxin | Cytarabine may reduce intestinal absorption of cardiac glycosides, leading to decreased blood levels | Monitor digoxin levels and cardiac function; dose adjustment may be required |
| Methotrexate | When used with intrathecal cytarabine, has been associated with increased risk of neurological toxicity including headache, paralysis, and coma | Heightened neurological monitoring is essential; report any new symptoms immediately |
| Gentamicin | Potential additive toxicity, particularly nephrotoxicity and ototoxicity; in vitro studies suggest reduced gentamicin activity | Monitor kidney function and hearing; use alternative antibiotics if possible |
| Idarubicin | Combination increases myelosuppression and may enhance cardiotoxicity | Used intentionally in treatment protocols; requires close cardiac and hematologic monitoring |
Other Interactions
Cytarabine is frequently used in combination with other chemotherapy agents as part of established treatment protocols. These intentional combinations include:
- Cyclophosphamide, vincristine, and prednisone: Used in various leukemia and lymphoma treatment regimens. While these combinations are clinically validated, they require careful dose management and close monitoring for cumulative toxicities, especially bone marrow suppression.
- Anthracyclines (e.g., daunorubicin, idarubicin): Commonly combined with cytarabine in the standard “7+3” induction regimen for AML. This combination increases the risk of myelosuppression and cardiotoxicity, necessitating cardiac monitoring.
- Immunosuppressive agents (azathioprine, mercaptopurine): These drugs further suppress the immune system when used alongside cytarabine, increasing the risk of serious infections. Enhanced infection surveillance is required.
Because cytarabine profoundly suppresses the immune system, live vaccines should be avoided during treatment and for a period afterward. Even inactivated vaccines may not produce an adequate immune response due to the immunosuppressed state.
Pharmaceutical Incompatibilities
Cytarabine solutions are reported to be physically or chemically incompatible with a number of other intravenous drugs. These include carbenicillin sodium, cephalotin sodium, fluorouracil, gentamicin sulfate, heparin sodium, hydrocortisone sodium succinate, regular insulin, methylprednisolone sodium succinate, nafcillin sodium, oxacillin sodium, penicillin G sodium, and prednisolone succinate. The degree of incompatibility depends on concentration, diluent, pH, and temperature. Cytarabine Accord should not be mixed with other medicines except the recommended diluents (sterile water for injections, 5% glucose, or 0.9% sodium chloride).
What Is the Correct Dosage of Cytarabine Accord?
Quick Answer: Cytarabine Accord dosing is highly individualized based on the patient’s body surface area, type of leukemia, treatment phase (induction vs. maintenance), route of administration, and overall health status. It is always determined by the treating oncologist and administered in a hospital setting. This 20 mg/ml formulation is suitable for intravenous, subcutaneous, intramuscular, and intrathecal use.
The dosage of Cytarabine Accord varies significantly depending on the specific treatment protocol being followed, the type and stage of leukemia, whether the treatment is for induction, consolidation, or maintenance, and individual patient factors such as age, kidney and liver function, and bone marrow reserve. Your oncologist will calculate your dose based on your body surface area (BSA), determined from your height and weight. The 20 mg/ml concentration of Cytarabine Accord is particularly suitable for intrathecal administration and subcutaneous injection, where lower volumes are preferred.
Adults
Induction Therapy (Intravenous)
Standard-dose induction typically involves cytarabine at 100–200 mg/m² per day administered as a continuous intravenous infusion over 24 hours for 7 consecutive days, usually in combination with an anthracycline given on days 1–3 (the “7+3” regimen). High-dose cytarabine (HiDAC) regimens use doses of 1–3 g/m² administered intravenously over 1–3 hours every 12 hours, typically for 4–12 doses depending on the protocol.
Consolidation Therapy
After achieving remission, consolidation therapy often uses intermediate to high doses of cytarabine. Common regimens include 1.5–3 g/m² every 12 hours on days 1, 3, and 5 of each consolidation cycle, for 2–4 cycles. The goal is to eliminate residual leukemia cells that survived induction therapy.
Maintenance Therapy
Maintenance doses are significantly lower than induction doses. Typical maintenance regimens use subcutaneous injections of 10–20 mg/m² once or twice daily, or periodic short courses of low-dose intravenous cytarabine. The 20 mg/ml concentration of Cytarabine Accord is particularly convenient for subcutaneous maintenance dosing.
Intrathecal Administration
For the prevention or treatment of meningeal leukemia, cytarabine is injected directly into the cerebrospinal fluid via lumbar puncture. Typical intrathecal doses range from 5–75 mg/m² depending on the protocol. The 20 mg/ml formulation of Cytarabine Accord is well-suited for this route. Important: Intrathecal cytarabine must be prepared preservative-free and used without benzyl alcohol-containing diluents.
Children
Cytarabine Accord is approved for use in pediatric patients. Dosing in children follows similar principles as in adults, calculated based on body surface area. Pediatric treatment protocols are typically defined by collaborative study groups such as the Children’s Oncology Group (COG) or the International BFM Study Group. Special attention is given to the risk of central nervous system toxicity when cytarabine is used in combination with intrathecal methotrexate, as cases of headache, paralysis, coma, and stroke-like symptoms have been reported in children and adolescents receiving this combination.
Elderly Patients
Older adults (over 55 years of age) may be more sensitive to the myelosuppressive and neurotoxic effects of cytarabine, particularly at high doses. Age-adjusted dosing regimens and enhanced monitoring are often appropriate. The risk of cerebellar toxicity is notably higher in elderly patients. The decision to use standard versus reduced-intensity protocols is made by the treating oncologist based on the patient’s overall fitness, organ function, and comorbidities.
Administration Notes
Because Cytarabine Accord is administered in a hospital or clinical setting by healthcare professionals, the issue of a missed dose in the traditional sense does not apply. Treatment schedules are carefully planned and managed by the medical team. If a dose is delayed or needs to be modified, your oncologist will adjust the treatment plan accordingly based on clinical circumstances, blood counts, and overall tolerance.
Overdose
High doses of cytarabine can worsen side effects, particularly mouth ulcers (oral mucositis) and severe reduction in white blood cells (leukopenia) and platelets (thrombocytopenia). Overdose can also lead to serious nerve damage, severe lung disease, heart problems, and can potentially be fatal. In the event of an overdose, supportive care measures including antibiotics, blood transfusions, and treatment of oral ulcers may be required. There is no specific antidote for cytarabine overdose. Contact your healthcare team or emergency services immediately if an overdose is suspected.
Regular Monitoring During Treatment
During Cytarabine Accord treatment, you will need regular check-ups and blood tests. Your healthcare team will monitor:
- Complete blood count (CBC): To assess white blood cells, red blood cells, and platelets. Low counts may require treatment with growth factors, antibiotics, or blood transfusions.
- Liver function tests: Blood tests to ensure cytarabine is not adversely affecting your liver.
- Kidney function tests: Blood tests to monitor creatinine and other markers of kidney health.
- Uric acid levels: As cancer cells are destroyed, uric acid is released into the bloodstream. Elevated levels can damage the kidneys, so preventive medication (such as allopurinol or rasburicase) may be given.
- Neurological assessment: Particularly important during high-dose regimens, to detect early signs of cerebellar toxicity (difficulty with balance, coordination, and speech).
What Are the Side Effects of Cytarabine Accord?
Quick Answer: Cytarabine causes significant side effects, the most common being bone marrow suppression (myelosuppression), fever, nausea, vomiting, diarrhea, mouth ulcers, liver enzyme elevation, and skin reactions. High-dose regimens carry additional risks including cerebellar toxicity, pulmonary complications, and severe skin reactions. Cytarabine syndrome—fever, bone pain, and malaise—can occur 6–12 hours after treatment.
Like all chemotherapy drugs, Cytarabine Accord can cause side effects, although not everyone experiences all of them. The type and severity of side effects depend primarily on the dose administered. Gastrointestinal side effects are the most common, but blood-related side effects are also significant. Side effects from the gastrointestinal tract tend to be less frequent when cytarabine is given as a continuous infusion rather than rapid injection.
Sudden signs of allergic reaction (rash, itching, hives, facial or lip swelling, difficulty breathing or wheezing), signs of severe infection or sepsis (fever or low body temperature, rapid breathing, increased heart rate, confusion, swelling), spinal cord damage causing paralysis, weakness or numbness in extremities, seizures or loss of consciousness, complete vision loss, severe sharp chest pain spreading to shoulders and neck, severe abdominal pain with vomiting or blood in stool, or difficulty urinating.
Side Effects by Frequency
Common
May affect up to 1 in 10 patients
- Fever
- Abnormal blood cells (megaloblastosis)
- Decreased appetite
- Difficulty swallowing (dysphagia)
- Abdominal pain
- Nausea and vomiting
- Diarrhea
- Inflammation or ulcers of the mouth or rectum
- Elevated liver enzymes (transient)
- Skin redness (erythema), blistering, rash, hives
- Blood vessel inflammation (vasculitis)
- Hair loss (at high doses)
- Kidney problems (seen in blood or urine tests)
- Elevated uric acid levels in the blood (hyperuricemia)
- Reduced consciousness (at high doses)
- Speech difficulties (at high doses)
- Abnormal eye movements – nystagmus (at high doses)
Uncommon
May affect up to 1 in 100 patients
- Sore throat
- Headache
- Inflammation and ulcers in the esophagus
- Brown or black spots on the skin (lentigo)
- Skin ulcers
- Numbness in arms and legs
- Itching (pruritus)
- Shortness of breath (dyspnea)
- Joint and muscle pain
Very Rare
May affect up to 1 in 10,000 patients
- Skin blisters and rash
- Irregular heartbeat (arrhythmia)
Frequency Not Known
Frequency cannot be estimated from available data
- Dizziness
- Painful swelling of arms or legs
- Freckles on the skin
- Chest pain
- Burning pain in palms of hands and soles of feet
- Slower than normal heartbeat (bradycardia)
- Low reticulocyte count (precursors to red blood cells)
- Low white blood cell count (neutropenia)
- Febrile neutropenia (malaise and fever due to low white blood cells)
Cytarabine Syndrome
Cytarabine syndrome is a recognized constellation of symptoms that can develop 6–12 hours after the start of treatment. It is an important side effect to be aware of, as it can be mistaken for infection or disease progression. Symptoms include:
- Fever
- Bone and muscle pain (myalgia)
- Sore eyes (conjunctivitis)
- General malaise and feeling unwell
- Transient chest pain
- Skin rash
- Nausea
Your doctor may prescribe corticosteroids (anti-inflammatory medicines such as hydrocortisone, prednisolone, or dexamethasone) to prevent or treat these symptoms. If the corticosteroids are effective in managing the syndrome, treatment with cytarabine can be continued safely.
Side Effects After Intrathecal Administration
When cytarabine is injected into the area around the spinal cord (intrathecal administration), additional side effects may develop related to the central nervous system. These can include inflammation of the membranes around the brain and spinal cord (arachnoiditis), which may cause severe headache, numbness or tingling in the hands and feet, nausea, and vomiting. These symptoms require immediate medical attention.
Side Effects with High-Dose Treatment
When cytarabine is used at high doses, additional neurological side effects may occur in up to one-third of patients. These effects, which often resolve after treatment is stopped, include:
- Personality changes
- Altered alertness and drowsiness
- Problems with coordination and balance (cerebellar toxicity)
- Confusion
- Tremors
These high-dose side effects occur more frequently in:
- Patients over 55 years of age
- Patients with impaired liver or kidney function
- Patients who have received previous cancer treatment to the brain and spinal cord
- Patients with a history of alcohol misuse
The risk of nervous system damage increases when cytarabine treatment is given at high doses, at short intervals, or in combination with other treatments that are toxic to the nervous system (such as radiation therapy or methotrexate).
How Should You Store Cytarabine Accord?
Quick Answer: Store at no more than 25°C (77°F). Protect from cold and do not freeze. The solution should be clear, colorless, and free from visible particles. After dilution, the solution is chemically stable for up to 8 days at 25°C, but should be used immediately from a microbiological standpoint unless prepared under validated aseptic conditions.
Proper storage of Cytarabine Accord is essential to maintain its safety and effectiveness. As a cytotoxic medication, special handling and disposal procedures apply. Healthcare professionals responsible for the preparation and administration of this drug should follow established protocols for the safe handling of cytotoxic agents, including the use of protective gloves, gowns, and eye protection. Pregnant staff should not handle cytotoxic drugs.
- Temperature: Store at no more than 25°C (77°F). Protect from cold temperatures. The solution must not be frozen.
- Visual inspection: Do not use the solution if it is not clear, colorless, or if it contains visible particles. A clear, particle-free solution indicates proper quality.
- After dilution: Cytarabine Accord is a ready-to-use solution but can be diluted with sterile water for injections, 5% glucose, or 0.9% sodium chloride. Chemical and physical stability has been demonstrated at concentrations of 0.04 mg/ml, 0.1 mg/ml, 1.0 mg/ml, and 4.0 mg/ml for up to 8 days at 25°C. However, from a microbiological perspective, the diluted solution should ideally be used immediately unless the dilution method excludes the risk of microbial contamination.
- Do not use after the expiry date printed on the vial or carton. If only the month and year are shown, this refers to the last day of that month.
- Keep out of the sight and reach of children.
Cytarabine is a cytotoxic substance. Unused medicine and waste materials should be disposed of in accordance with local requirements for hazardous pharmaceutical waste. Do not dispose of medications in household waste or down the drain. In the event of a spill, wear gloves and safety glasses, clean up with absorbent materials, rinse the area thoroughly with water, and dispose of all contaminated materials in a cytotoxic waste bag for incineration.
Packaging Information
Cytarabine Accord 20 mg/ml is supplied in clear glass vials with butyl rubber stoppers:
| Vial Size | Cytarabine Content | Cap Color | Pack Sizes |
|---|---|---|---|
| 2 ml | 40 mg | Blue aluminum flip-off cap | 1, 5, or 25 vials |
| 5 ml | 100 mg | Red aluminum flip-off cap | 1, 5, or 25 vials |
Glass vials are supplied inside an outer plastic overwrap with a non-PVC base. Not all pack sizes may be marketed in all countries.
What Does Cytarabine Accord Contain?
Quick Answer: The active substance is cytarabine at a concentration of 20 mg per milliliter. Each 2 ml vial contains 40 mg of cytarabine, and each 5 ml vial contains 100 mg of cytarabine. Other ingredients include sodium chloride, sodium hydroxide (for pH adjustment), concentrated hydrochloric acid (for pH adjustment), and water for injections.
Understanding the full composition of a medication is important for identifying potential allergens and understanding the formulation. Cytarabine Accord is a clear, colorless solution for injection or infusion that is free from visible particles. It is supplied as a ready-to-use solution that can also be further diluted for specific administration routes.
Active Ingredient
Each milliliter of solution contains 20 mg of cytarabine. The available vial sizes are:
- 2 ml vial: Contains 40 mg cytarabine
- 5 ml vial: Contains 100 mg cytarabine
Inactive Ingredients (Excipients)
- Sodium chloride: Tonicity agent to match the solution to body fluids
- Sodium hydroxide: Used for pH adjustment
- Hydrochloric acid, concentrated: Used for pH adjustment
- Water for injections: Solvent
The solution is supplied in clear Type I glass vials sealed with butyl rubber stoppers and color-coded aluminum flip-off caps (blue for 2 ml, red for 5 ml) for easy identification.
Marketing Authorization
The marketing authorization holder is Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, The Netherlands. The medicine is manufactured by Laboratori Fundació Dau, Barcelona, Spain, and Accord Healthcare Polska Sp.z o.o., Pabianice, Poland.
Frequently Asked Questions About Cytarabine Accord
Cytarabine Accord is used to treat acute leukemias (cancers of the blood involving excessive white blood cells) in both adults and children. It is used for both induction of remission (intensive initial treatment) and maintenance therapy (lower-dose treatment to sustain remission). Additionally, it is used for the prevention and treatment of meningeal leukemia, where leukemia cells have spread to the membranes surrounding the brain and spinal cord. Cytarabine is recognized by the World Health Organization as an essential medicine for the treatment of acute leukemias.
Cytarabine Accord can be administered by several routes: intravenous injection or infusion (into a vein), subcutaneous injection (under the skin), intramuscular injection (into a muscle), or intrathecal injection (directly into the spinal fluid). The choice of route depends on the specific treatment protocol and the goal of therapy. It is always administered under the supervision of specialized healthcare professionals in a hospital or clinical setting, and is never self-administered at home.
Common side effects (affecting up to 1 in 10 patients) include fever, nausea, vomiting, diarrhea, abdominal pain, inflammation or ulcers of the mouth and rectum, decreased appetite, elevated liver enzymes, skin rash and redness, elevated uric acid levels, and kidney changes. Cytarabine syndrome (a flu-like reaction with fever, bone pain, conjunctivitis, and malaise occurring 6–12 hours after treatment) is also well documented. At high doses, hair loss, reduced consciousness, and speech difficulties can also occur.
No, Cytarabine Accord must not be used during pregnancy as it can cause severe birth defects. Both men and women must use effective contraception during treatment. Women of childbearing age should continue contraception for at least 6 months after the last dose, and male patients for at least 3 months. Women must stop breastfeeding before starting treatment, as the drug may pass into breast milk and be harmful to the nursing infant. Patients who wish to have children in the future should discuss fertility preservation options before starting treatment.
Cytarabine syndrome is a recognized side effect characterized by a constellation of symptoms occurring 6–12 hours after cytarabine treatment begins. Symptoms include fever, bone and muscle pain, conjunctivitis (sore eyes), general malaise, transient chest pain, skin rash, and nausea. It is distinct from an allergic reaction or infection, though it can mimic them. The syndrome can be prevented or treated with corticosteroids such as hydrocortisone, prednisolone, or dexamethasone. If corticosteroids are effective, treatment with cytarabine can be safely continued.
Cytarabine Accord should be stored at no more than 25°C (77°F). It must be protected from cold and must not be frozen. The solution should be clear, colorless, and free from visible particles before use. After dilution, chemical and physical stability has been demonstrated for 8 days at 25°C, but from a microbiological standpoint it should be used immediately unless the dilution was performed under validated aseptic conditions. Always keep out of the sight and reach of children.
References
This article is based on the following peer-reviewed sources and international guidelines:
- European Medicines Agency (EMA). Cytarabine – Summary of Product Characteristics. Available at: www.ema.europa.eu.
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List, 2023. Geneva: WHO; 2023.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Acute Myeloid Leukemia. Version 3.2024.
- Döhner H, Wei AH, Appelbaum FR, et al. Diagnosis and Management of AML in Adults: 2022 ELN Recommendations from an International Expert Panel. Blood. 2022;140(12):1345-1377. doi:10.1182/blood.2022016867
- Burnett AK, Russell NH, Hills RK, et al. Optimization of chemotherapy for younger patients with acute myeloid leukemia: results of the MRC AML15 trial. J Clin Oncol. 2013;31(27):3360-3368.
- British National Formulary (BNF). Cytarabine. Available at: bnf.nice.org.uk.
- U.S. Food and Drug Administration (FDA). Cytarabine – Prescribing Information. Available at: www.fda.gov.
- Tallman MS, Wang ES, Altman JK, et al. Acute Myeloid Leukemia, Version 3.2019, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019;17(6):721-749.
- Lowenberg B, Pabst T, Vellenga E, et al. Cytarabine dose for acute myeloid leukemia. N Engl J Med. 2011;364(11):1027-1036.
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, consisting of licensed specialist physicians with expertise in oncology, hematology, and clinical pharmacology.
iMedic Medical Editorial Team – Specialists in Oncology and Hematology
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