Cytarabin Fresenius Kabi
Cytarabine 100 mg/ml – Solution for Injection or Infusion
Cytarabin Fresenius Kabi contains the active substance cytarabine, a potent chemotherapy drug belonging to the antimetabolite class. It is used to treat acute leukemias in both adults and children. Administered intravenously or subcutaneously under specialist supervision in hospitals, cytarabine works by disrupting DNA synthesis in cancer cells, ultimately destroying them. This guide provides comprehensive information about its uses, dosage, side effects, interactions, and storage.
Quick Facts
Key Takeaways
- Cytarabine is a chemotherapy drug used primarily for acute leukemias, both for inducing remission and maintaining it long-term.
- It is administered only in hospital settings by specialized healthcare professionals experienced in cancer treatment.
- Bone marrow suppression is the most significant side effect, requiring regular blood monitoring throughout treatment.
- Both men and women must use effective contraception during treatment and for 6 months afterward due to the risk of birth defects.
- Cytarabine syndrome—fever, bone pain, and malaise occurring 6–12 hours after treatment—is a common but treatable side effect.
What Is Cytarabin Fresenius Kabi and What Is It Used For?
Quick Answer: Cytarabin Fresenius Kabi is a chemotherapy medication containing cytarabine, an antimetabolite that belongs to the pyrimidine analogue group. It is used to treat acute leukemias (cancers of the blood) in both adults and children by disrupting DNA synthesis in rapidly dividing cancer cells.
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). It has been a fundamental part of leukemia treatment protocols for decades and remains an essential component of modern combination chemotherapy regimens recommended by international guidelines including those from the National Comprehensive Cancer Network (NCCN) and the European LeukemiaNet (ELN).
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 or ara-CTP), which competes with the normal nucleotide deoxycytidine triphosphate for incorporation into DNA during the S-phase of cell division. This incorporation disrupts DNA synthesis and leads to chain termination and cell death.
Cytarabine is used for two main 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's health improves significantly. This relatively healthy period is called remission. Induction therapy typically involves higher doses of cytarabine, often in combination with other chemotherapy drugs such as anthracyclines.
- Maintenance therapy: Once remission has been achieved, maintenance treatment uses lower doses of cytarabine to prolong the remission period for as long as possible. The goal is to keep the leukemia under control and prevent relapse. Maintenance therapy is generally less intensive and better tolerated than induction treatment.
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. According to the World Health Organization (WHO) Model List of Essential Medicines, cytarabine is considered an essential medicine for the treatment of acute leukemias worldwide.
Cytarabine 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.
What Should You Know Before Taking Cytarabin Fresenius Kabi?
Quick Answer: Before starting cytarabine treatment, your doctor must assess your overall health, blood counts, liver and kidney function, and vaccination history. Certain conditions—including severe allergies to cytarabine, very low blood counts from non-cancerous causes, and prior severe brain damage from chemotherapy or radiation—are absolute contraindications.
Before beginning treatment with cytarabine, 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 treatment.
Contraindications
You must not receive Cytarabin Fresenius Kabi 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 (hydrochloric acid, sodium hydroxide, water for injections), this medication must not be used.
- 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), cytarabine should generally not be administered, as it would further suppress blood cell production.
- Previous severe brain damage (encephalopathy): If you have experienced severe encephalopathy following radiation therapy or treatment with other chemotherapy drugs such as methotrexate, cytarabine should not be used due to the risk of worsening neurological damage.
Warnings and Precautions
Special caution is required in the following situations:
- 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 and bleeding. 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.
- Liver function: Your liver function should be monitored throughout treatment. If your liver is not functioning well before treatment begins, cytarabine should only be given under close medical supervision, as the drug is metabolized primarily by the liver.
- Kidney function: Kidney function should also be monitored during treatment, particularly because high levels of uric acid (hyperuricemia) can develop as cancer cells are destroyed. Your doctor may prescribe medication (such as allopurinol) to control uric acid levels and protect the kidneys.
- Vaccinations: Live or live-attenuated vaccines should generally be avoided during cytarabine treatment due to the compromised immune state. Discuss any planned vaccinations with your healthcare team before and after treatment.
- Central nervous system toxicity: Serious and sometimes life-threatening adverse effects can occur affecting the brain, intestines, or lungs. High-dose cytarabine regimens carry a particularly elevated risk of cerebellar toxicity, which can cause difficulty with coordination, speech, and balance.
Pregnancy and Breastfeeding
Cytarabine can cause severe birth defects and must not be used during pregnancy unless the potential benefit clearly outweighs the risk to the fetus. Both male and female patients must use effective contraception during treatment and for at least 6 months after the last dose. If you suspect you are pregnant, inform your doctor immediately. Women must stop breastfeeding before starting cytarabine treatment, as the drug may be harmful to nursing infants.
Cytarabine has been shown to be teratogenic (capable of causing birth defects) and embryotoxic in animal studies. There is a clear risk of fetal harm when administered during pregnancy. For this reason, both male and female patients of reproductive age are required to use highly effective contraception throughout the course of treatment and for at least six months after the last dose. Men should be aware that cytarabine may cause temporary or permanent absence of sperm (azoospermia), and women may experience cessation of menstrual periods (amenorrhea) during treatment.
Driving and Using Machines
If you feel unwell after cytarabine treatment, you should not drive or operate machinery. Side effects such as dizziness, drowsiness, confusion, and visual disturbances can impair your ability to perform these activities safely. You are responsible for assessing whether you are fit to drive or perform tasks requiring alertness.
Sodium Content
This medicine contains less than 1 mmol sodium (23 mg) per dose, meaning it is essentially sodium-free. This is relevant for patients on a sodium-restricted diet.
How Does Cytarabin Fresenius Kabi 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 (reduced absorption), gentamicin (additive toxicity), and intrathecal methotrexate (increased neurological risk in pediatric patients).
Drug interactions are an important consideration when using cytarabine, as patients undergoing chemotherapy often receive multiple medications for supportive care, infection prevention, and treatment of concurrent conditions. 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.
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 |
| Digitoxin / 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 (intrathecal) | Combination with IV cytarabine has been associated with headache, paralysis, coma, and stroke-like symptoms in children and adolescents | Heightened neurological monitoring is essential; report any new symptoms immediately |
| Gentamicin | Potential additive toxicity, particularly nephrotoxicity and ototoxicity | Monitor kidney function and hearing; use alternative antibiotics if possible |
Other Interactions
Cytarabine is frequently used in combination with other chemotherapy agents as part of established treatment protocols. These combinations include:
- Cyclophosphamide, vincristine, and prednisone: Used in various leukemia treatment regimens. While these combinations are intentionally designed and clinically validated, they require careful dose management and close monitoring for cumulative toxicities.
- 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.
Because cytarabine profoundly suppresses the immune system, live vaccines should be avoided during treatment and for a period afterward, as the body may not be able to mount an adequate immune response, and there is a risk of vaccine-related infection.
What Is the Correct Dosage of Cytarabin Fresenius Kabi?
Quick Answer: Cytarabine dosing is highly individualized based on the patient's body surface area, type of leukemia, treatment phase (induction vs. maintenance), and overall health status. It is always determined by the treating oncologist and administered in a hospital setting. Standard induction doses typically range from 100–200 mg/m² per day, while high-dose regimens may use 1–3 g/m².
The dosage of cytarabine varies significantly depending on the specific treatment protocol being followed, the type and stage of leukemia, whether the treatment is for induction 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), which is determined from your height and weight.
Adults
Induction Therapy
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 (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 for 2–6 days, 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.
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, often in combination with other agents.
Children
Cytarabine 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) and are disease-specific. 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 this population.
Elderly Patients
Older adults may be more sensitive to the myelosuppressive and neurotoxic effects of cytarabine, particularly at high doses. Age-adjusted dosing regimens and enhanced monitoring may be appropriate. 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 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 modified, your oncologist will adjust the treatment plan accordingly based on clinical circumstances.
Overdose
High doses of cytarabine can worsen side effects, particularly mouth ulcers and severe reduction in white blood cells and platelets. 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 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 (e.g., 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 Cytarabin Fresenius Kabi?
Quick Answer: Cytarabine causes significant side effects, the most common being bone marrow suppression (myelosuppression), infections, nausea, vomiting, diarrhea, mouth ulcers, liver damage, hair loss, and cytarabine syndrome. High-dose regimens carry additional risks including cerebellar toxicity, pulmonary edema, and severe skin reactions.
Like all chemotherapy drugs, cytarabine can cause side effects, although not everyone experiences all of them. The type and severity of side effects depend on the dose, duration of treatment, whether cytarabine is used alone or in combination with other drugs, and individual patient factors. It is important to report any new or worsening symptoms to your healthcare team promptly.
Allergic reactions (sudden wheezing, difficulty breathing, swelling of eyelids, face, or lips, rash or itching affecting the whole body), signs of severe infection (high fever, chills, sore throat), unusual bruising or bleeding, or chest pain and breathing difficulties.
Standard-Dose Side Effects
Very Common
May affect more than 1 in 10 patients
- Infections (including pneumonia), which can become severe and lead to organ failure
- Reduced production of red blood cells, white blood cells, and platelets (myelosuppression)
- Inflammation or ulcers of the mouth, lips, or anus
- Nausea, vomiting, diarrhea, abdominal pain
- Liver damage (detected through blood tests)
- Hair loss (usually reversible after treatment ends)
- Skin rash
- Cytarabine syndrome: malaise, fever, bone and muscle pain, chest pain, skin blisters, sore eyes (occurring 6–12 hours after treatment)
- Fever
- Abnormal bone marrow or blood test results
Common
May affect up to 1 in 10 patients
- Skin ulceration
- Elevated uric acid levels in the blood (hyperuricemia)
- Difficulty swallowing (dysphagia)
Uncommon
May affect up to 1 in 100 patients
- Gas-filled cysts in the intestinal wall (pneumatosis cystoides intestinalis)
- Severe intestinal inflammation (necrotizing colitis)
- Severe infection of the abdominal lining (peritonitis)
Very Rare / Frequency Not Known
May affect fewer than 1 in 10,000 patients or frequency cannot be estimated
- Irregular heartbeat (arrhythmia)
- Inflammation of sweat glands
- Inflammation of the membrane around the heart (pericarditis)
- Slowed heart rate (bradycardia)
- Inflammation of veins (thrombophlebitis)
- Pancreatitis
- Jaundice (yellowing of skin and eyes)
- Skin redness resembling sunburn, joint and facial numbness
- Difficulty urinating, blood in urine, reduced kidney function
- Headache, dizziness, tingling sensations, tremors, seizures, drowsiness
- Sore and itchy eyes
- Shortness of breath, sore throat
- Loss of appetite
Additional Side Effects with High-Dose Treatment
When cytarabine is used at high doses (typically 1–3 g/m²), additional side effects may occur. These are generally more severe and require intensive monitoring:
Very Common (High-Dose)
May affect more than 1 in 10 patients
- Cerebellar toxicity: impaired alertness, speech difficulties, involuntary movements, coordination problems, involuntary eye movements, headache, confusion, drowsiness, dizziness
- Eye infections, irritation, pain, blurred vision, and vision loss
- Chest pain, fluid accumulation in the lungs (pulmonary edema)
Common (High-Dose)
May affect up to 1 in 10 patients
- Skin peeling (desquamation)
- Intestinal infection and inflammation, particularly in infants
Reported (High-Dose, Frequency Unknown)
Frequency cannot be estimated from available data
- Liver abscess, enlarged liver
- Personality changes
- Coma, seizures, balance disorders due to nerve damage
- Cardiomyopathy (weakened heart muscle), which can be life-threatening
- Blood in vomit or stool, tissue death in the gastrointestinal tract
- Budd-Chiari syndrome (blood clots in liver veins)
- Rhabdomyolysis (muscle breakdown)
- Amenorrhea (absence of menstruation) and azoospermia (absence of sperm)
How Should You Store Cytarabin Fresenius Kabi?
Quick Answer: Store at 15–25°C (59–77°F). Protect from cold and do not freeze. Use immediately after opening. After dilution, the solution is chemically stable for up to 8 days at 25°C, but should be used within 24 hours from a microbiological standpoint unless prepared under validated aseptic conditions.
Proper storage of cytarabine is essential to maintain its safety and effectiveness. As a cytotoxic medication, special handling and disposal procedures apply. The following guidelines should be followed:
- Temperature: Store at 15–25°C (59–77°F). Protect from cold temperatures. The solution must not be frozen.
- After opening: The contents of each vial should be used immediately after opening. Any unused portion should be discarded according to local regulations for cytotoxic waste.
- After dilution: When diluted with sterile water for injections, glucose 5% solution, or sodium chloride 0.9% solution, chemical and physical stability has been demonstrated for 8 days at 25°C. However, from a microbiological perspective, the diluted solution should ideally be used immediately. If not used immediately, in-use storage should normally not exceed 24 hours at 2–8°C, unless dilution was performed under controlled and validated aseptic conditions.
- Visual inspection: Do not use the solution if it appears cloudy, discolored, or contains visible particles. It should be clear and colorless.
- Crystallization: If crystals form due to exposure to low temperatures, dissolve them by warming the vial to 55°C for up to 30 minutes and shaking until dissolved. Allow to cool to room temperature before use.
- Keep out of reach of children.
- Do not use after the expiry date printed on the vial or carton.
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. Ask your pharmacist about proper disposal procedures.
What Does Cytarabin Fresenius Kabi Contain?
Quick Answer: The active substance is cytarabine at a concentration of 100 mg/ml. Each vial contains either 100 mg (1 ml), 500 mg (5 ml), 1000 mg (10 ml), or 2000 mg (20 ml) of cytarabine. Other ingredients include hydrochloric acid, sodium hydroxide (for pH adjustment), and water for injections.
Understanding the full composition of a medication is important for identifying potential allergens and understanding the formulation. Cytarabin Fresenius Kabi is a clear, colorless solution for injection or infusion supplied in Type I glass vials.
Active Ingredient
Each milliliter of solution contains 100 mg of cytarabine. The available vial sizes are:
| Vial Size | Cytarabine Content | Cap Color |
|---|---|---|
| 1 ml | 100 mg | Green |
| 5 ml | 500 mg | Blue |
| 10 ml | 1000 mg | Red |
| 20 ml | 2000 mg | Yellow |
Inactive Ingredients (Excipients)
- Hydrochloric acid: Used for pH adjustment
- Sodium hydroxide: Used for pH adjustment
- Water for injections: Solvent
The medicine is supplied in clear, colorless Type I glass vials sealed with bromobutyl rubber stoppers and aluminum flip-off caps. Each carton contains 1 vial. Not all pack sizes may be marketed in all countries.
Marketing Authorization
The marketing authorization holder is Fresenius Kabi AB. The medicine is manufactured by Fresenius Kabi Deutschland GmbH, Friedberg, Germany. It is approved in multiple countries across the European Economic Area under various trade names including Cytarabine Kabi and Cytarabin Fresenius Kabi.
Frequently Asked Questions About Cytarabin Fresenius Kabi
Cytarabin Fresenius Kabi is used to treat acute leukemias (cancers of the blood involving excessive white blood cells). It is used for both induction of remission (intensive treatment to push the leukemia into remission) and maintenance therapy (lower-dose treatment to prolong remission and prevent relapse). It is approved for use in both adults and children. Cytarabine is considered an essential medicine by the World Health Organization for the treatment of acute leukemias.
Cytarabine is administered by intravenous infusion (IV drip) or by subcutaneous injection, always under the supervision of specialists in a hospital setting. The dose, route, and duration of treatment are determined by the treating physician based on the patient's condition, body surface area, and the specific treatment protocol being followed. It is never self-administered at home.
Very common side effects (affecting more than 1 in 10 patients) include bone marrow suppression (reduced production of blood cells), infections (including pneumonia), inflammation or ulcers of the mouth and anus, nausea, vomiting, diarrhea, abdominal pain, liver damage (seen in blood tests), hair loss, skin rash, fever, and cytarabine syndrome (a flu-like reaction with fever, bone pain, and malaise occurring 6–12 hours after treatment).
No, cytarabine should generally not be used during pregnancy as it can cause severe birth defects. Both men and women must use effective contraception during treatment and for at least 6 months after the last dose. If pregnancy is suspected, the treating physician must be informed immediately. Women should also stop breastfeeding before starting cytarabine treatment, as the drug may pass into breast milk and be harmful to the nursing infant.
Cytarabine syndrome is a recognized side effect characterized by a constellation of symptoms occurring 6–12 hours after cytarabine treatment. Symptoms include general malaise, fever, bone and muscle pain, occasional chest pain, skin blisters, and sore eyes. While uncomfortable, it is generally treatable with supportive care measures prescribed by the healthcare team, such as corticosteroids. It is distinct from an allergic reaction and does not necessarily require discontinuation of treatment.
Cytarabin Fresenius Kabi should be stored at 15–25°C (59–77°F). It must be protected from cold and must not be frozen. The product should be used immediately after opening. After dilution, chemical stability has been demonstrated for 8 days at 25°C, but from a microbiological standpoint it should be used immediately or within 24 hours when stored at 2–8°C. If crystals form due to cold exposure, warm the vial to 55°C for up to 30 minutes and shake until dissolved.
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
iMedic Medical Review Board – Independent review according to EMA, FDA, and WHO guidelines
Level 1A – Systematic reviews and meta-analyses of randomized controlled trials (GRADE framework)
No commercial funding or pharmaceutical company sponsorship. All content is independently produced.
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