AMGEVITA (Adalimumab)
Biosimilar TNF-alpha inhibitor for inflammatory and autoimmune conditions
AMGEVITA is a biosimilar medicine containing adalimumab, a human monoclonal antibody that targets tumor necrosis factor alpha (TNF-alpha). It is used to treat a wide range of inflammatory and autoimmune conditions including rheumatoid arthritis, psoriasis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, and more. AMGEVITA is administered by subcutaneous injection, typically every two weeks, and requires a prescription from a qualified healthcare provider.
Quick Facts
Key Takeaways
- AMGEVITA is a biosimilar to Humira, containing the same active substance adalimumab with equivalent efficacy and safety.
- It treats multiple inflammatory conditions including rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriasis, and more.
- The standard dose is 40 mg injected subcutaneously every two weeks, though loading doses and weekly dosing may be needed for certain conditions.
- Serious infections, including tuberculosis, must be screened for before starting treatment. Do not use AMGEVITA if you have a serious active infection.
- AMGEVITA is self-administered using a pre-filled SureClick pen, and patients should be trained on proper injection technique before first use.
What Is AMGEVITA and What Is It Used For?
Quick Answer: AMGEVITA is a biosimilar biologic medicine containing adalimumab, a human monoclonal antibody that blocks TNF-alpha. It is used to reduce inflammation in conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis, and non-infectious uveitis.
AMGEVITA contains the active substance adalimumab, a medicine that modulates the immune system. Adalimumab is a human monoclonal antibody, which is a type of protein that attaches to a specific target in the body. The target of adalimumab is a protein called tumor necrosis factor alpha (TNF-alpha), which is involved in the immune response and is found at elevated levels in the inflammatory diseases described below.
By binding to TNF-alpha, AMGEVITA reduces the inflammatory process in these conditions. As a biosimilar medicine, AMGEVITA has been shown to be equivalent to the reference product (Humira) in terms of quality, safety, and efficacy through extensive comparative clinical studies. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have both approved AMGEVITA for clinical use.
AMGEVITA is approved for the treatment of the following inflammatory conditions:
Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic inflammatory disease of the joints. AMGEVITA is used to treat moderate to severe active RA in adults, usually in combination with methotrexate. If methotrexate is unsuitable, AMGEVITA may be given alone. It is also used for severe, active, and progressive RA not previously treated with methotrexate. AMGEVITA slows the destruction of cartilage and bone caused by the disease and can improve physical function and daily activities.
Juvenile Idiopathic Arthritis
AMGEVITA is used to treat polyarticular juvenile idiopathic arthritis in patients aged 2 years and older, and enthesitis-related arthritis in patients aged 6 years and older. These are inflammatory joint diseases that typically first appear in childhood. Treatment is usually initiated after other disease-modifying drugs such as methotrexate have been tried without sufficient response.
Ankylosing Spondylitis and Axial Spondyloarthritis
Ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis are inflammatory diseases primarily affecting the spine. AMGEVITA is used in adults when other conventional treatments have been inadequate. It helps reduce pain, stiffness, and inflammation in the spinal joints, improving mobility and quality of life.
Psoriatic Arthritis
Psoriatic arthritis is a form of joint inflammation associated with the skin condition psoriasis. AMGEVITA is used to treat psoriatic arthritis in adults, helping to slow joint damage and improve physical function.
Plaque Psoriasis
AMGEVITA is used to treat moderate to severe plaque psoriasis in adults, and severe plaque psoriasis in children and adolescents aged 4 to 17 years who have not responded adequately to topical therapies or phototherapy. Plaque psoriasis causes red, scaly patches on the skin covered with silvery scales, and can also affect the nails.
Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic, often painful inflammatory skin disease characterised by tender nodules and abscesses, commonly in the armpits, groin, and under the breasts. AMGEVITA is used in adults and adolescents from 12 years of age, and can reduce the number of lumps and abscesses as well as the associated pain.
Crohn's Disease
Crohn's disease is a chronic inflammatory disease of the digestive tract. AMGEVITA is used to treat moderately to severely active Crohn's disease in adults and in children aged 6 to 17 years, when other treatments have been insufficient. It helps reduce the signs and symptoms of the disease and can induce and maintain remission.
Ulcerative Colitis
Ulcerative colitis is an inflammatory disease of the large intestine. AMGEVITA is used to treat moderately to severely active ulcerative colitis in adults and in children aged 6 to 17 years, when conventional therapies have not provided adequate response.
Non-Infectious Uveitis
Non-infectious uveitis is an inflammatory disease affecting parts of the eye. AMGEVITA is used to treat adults with non-infectious uveitis affecting the posterior segment of the eye, and children from 2 years of age with chronic non-infectious uveitis affecting the anterior segment. The inflammation can lead to decreased vision and the presence of floaters, which AMGEVITA helps reduce.
What Should You Know Before Taking AMGEVITA?
Quick Answer: Do not use AMGEVITA if you have a serious active infection (including tuberculosis or sepsis), moderate to severe heart failure, or if you are allergic to adalimumab. You must be screened for tuberculosis before starting treatment. Tell your doctor about all medical conditions, medications, and planned vaccinations before beginning AMGEVITA therapy.
Contraindications
- You are allergic to adalimumab or any other ingredient in this medicine
- You have a serious infection, including tuberculosis, sepsis (blood poisoning), or other opportunistic infections
- You have moderate or severe heart failure (NYHA class III/IV)
It is critically important that you inform your doctor if you have symptoms of infection such as fever, wounds, tiredness, or dental problems. You must also report any history of heart disease or heart failure. These conditions can be significantly worsened by TNF-alpha inhibitors such as AMGEVITA.
Warnings and Precautions
Talk to your doctor or pharmacist before using AMGEVITA. Below are the most important warnings and precautions you should be aware of:
Infections: AMGEVITA suppresses part of the immune system, which means you may be more susceptible to infections during treatment. These infections can be serious and include tuberculosis, viral, fungal, parasitic, or bacterial infections, and opportunistic infections. Some of these infections can be life-threatening. If you develop fever, wounds, persistent fatigue, or dental problems, contact your doctor promptly. Your doctor may advise you to temporarily stop AMGEVITA.
Tuberculosis (TB): Because TB has been reported in patients treated with adalimumab, your doctor will examine you for signs and symptoms of TB before starting treatment. This includes a detailed medical history, a chest X-ray, and a tuberculin skin test or interferon-gamma release assay. TB can develop during treatment even if you have received prophylactic TB treatment. Inform your doctor immediately if you develop a persistent cough, weight loss, low-grade fever, or lethargy.
Hepatitis B Virus (HBV): Inform your doctor if you are a carrier of HBV, have active HBV, or if you are at risk. AMGEVITA can cause reactivation of HBV, which in rare cases, particularly if combined with other immunosuppressive agents, can be life-threatening. Your doctor should test you for HBV before initiating treatment.
- Allergic Reactions: Stop injecting and seek immediate medical attention if you experience chest tightness, wheezing, dizziness, swelling, or rash. In rare cases these can be life-threatening.
- Demyelinating Disease: If you have or develop multiple sclerosis (MS), your doctor will assess whether AMGEVITA is appropriate. Report any visual changes, weakness in arms or legs, or numbness/tingling.
- Vaccinations: Live vaccines must not be given during AMGEVITA treatment. Ensure all recommended vaccinations are up to date before starting therapy.
- Heart Failure: If you have mild heart failure, your condition must be closely monitored. Report any worsening symptoms such as shortness of breath or swollen feet.
- Cancer Risk: Very rare cases of certain cancers (including lymphoma and leukaemia) have been observed in patients treated with TNF inhibitors. Patients with severe, long-standing rheumatoid arthritis may have a higher background risk for lymphoma. Report any new skin lesions or changes to existing lesions.
- Blood Disorders: Report persistent fever, easy bruising, bleeding, or pallor, as these may indicate that your body is not producing sufficient blood cells.
Patients Over 65: Older adults may be more susceptible to infections while using AMGEVITA. Both patients and their doctors should pay close attention to signs of infection. Dose adjustments are generally not needed based on age alone, but careful monitoring is essential.
Surgery and Dental Procedures: If you are scheduled for surgery or dental work, inform your healthcare provider that you are taking AMGEVITA. Your doctor may advise temporarily pausing treatment to reduce infection risk.
Autoimmune Conditions: In rare cases, AMGEVITA treatment can cause a lupus-like syndrome. If you develop persistent unexplained rash, fever, joint pain, or fatigue, contact your doctor. Treatment will typically be discontinued if this occurs.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, talk to your doctor before using AMGEVITA. AMGEVITA should only be used during pregnancy if clearly needed. According to a pregnancy study, there was no increased risk of birth defects when the mother used adalimumab during pregnancy compared to mothers with the same disease who did not use adalimumab.
AMGEVITA may be used during breastfeeding. However, if you received AMGEVITA during pregnancy, your newborn may have an increased risk of infection for up to approximately five months after the last dose given during pregnancy. It is important to inform your baby's paediatrician about your AMGEVITA use before the baby receives any vaccinations, particularly live vaccines.
Adequate contraception should be used during treatment and continued for at least 5 months after the last AMGEVITA dose.
Children and Adolescents
- Polyarticular juvenile idiopathic arthritis: From 2 years of age
- Enthesitis-related arthritis: From 6 years of age
- Plaque psoriasis: From 4 years of age
- Crohn's disease: From 6 years of age
- Ulcerative colitis: From 6 years of age
- Hidradenitis suppurativa: From 12 years of age
- Chronic non-infectious anterior uveitis: From 2 years of age
Children should receive all recommended vaccinations before starting AMGEVITA whenever possible.
Driving and Operating Machinery
AMGEVITA may have a minor effect on your ability to drive or operate machinery. Dizziness and visual disturbances may occur during treatment. If affected, do not drive or use machines until symptoms resolve.
How Does AMGEVITA Interact with Other Drugs?
Quick Answer: AMGEVITA must not be combined with anakinra or abatacept due to increased risk of serious infections. Live vaccines are contraindicated during treatment. AMGEVITA can be safely combined with methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, corticosteroids, and NSAIDs.
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or might take. Drug interactions with biologic agents can have serious clinical consequences, particularly regarding infection risk. Below is a comprehensive overview of known interactions.
| Interacting Drug | Severity | Effect | Recommendation |
|---|---|---|---|
| Anakinra (IL-1 receptor antagonist) | Major | Significantly increased risk of serious infections and neutropenia | Do not combine. Contraindicated. |
| Abatacept (T-cell co-stimulation modulator) | Major | Increased risk of serious infections without additional clinical benefit | Do not combine. Contraindicated. |
| Live vaccines (e.g. MMR, BCG, varicella) | Major | Risk of infection from live vaccine components due to immunosuppression | Do not administer during treatment. Vaccinate before starting AMGEVITA. |
| Other TNF inhibitors (e.g. etanercept, infliximab) | Major | Additive immunosuppression with no added benefit | Do not combine. Use only one TNF inhibitor at a time. |
| Azathioprine / 6-Mercaptopurine | Moderate | Possible increased risk of hepatosplenic T-cell lymphoma (rare) | Use with caution. Discuss risks with your doctor. |
| Methotrexate | Compatible | May reduce immunogenicity; commonly used in combination | Standard combination for RA. Safe and recommended. |
| NSAIDs (e.g. ibuprofen, naproxen) | Compatible | No significant interaction | Can be used together for symptom relief. |
| Corticosteroids (e.g. prednisolone) | Compatible | No significant interaction | Can be used together. Often used during initiation. |
Always inform all your healthcare providers, including dentists, that you are using AMGEVITA. Carry a patient alert card if one has been provided. This helps ensure that potential interactions are identified and managed appropriately in all clinical settings.
What Is the Correct Dosage of AMGEVITA?
Quick Answer: The standard adult dose is 40 mg injected subcutaneously every two weeks. However, doses vary significantly depending on the condition being treated, patient weight, age, and clinical response. Some conditions require higher initial loading doses. Always follow your doctor's specific instructions.
Always use AMGEVITA exactly as your doctor or pharmacist has instructed. The dosing regimen depends on the specific condition being treated, the patient's age and weight, and clinical response. Below is a comprehensive overview of recommended dosing.
Adult Dosing
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis & Axial Spondyloarthritis
Standard dose: 40 mg every other week (subcutaneous injection).
Usually combined with methotrexate for RA. If methotrexate is unsuitable, AMGEVITA may be given alone. If monotherapy provides insufficient response, your doctor may increase to 40 mg weekly or 80 mg every other week.
Plaque Psoriasis (Adults)
Loading dose: 80 mg (two 40 mg injections on one day).
Maintenance: 40 mg every other week, starting one week after the loading dose.
If response is insufficient, your doctor may increase to 40 mg weekly or 80 mg every other week.
Hidradenitis Suppurativa (Adults)
Day 1: 160 mg (four 40 mg injections in one day, or two injections per day over two days).
Week 2: 80 mg (two 40 mg injections).
Maintenance (from week 4): 40 mg weekly or 80 mg every other week.
Daily use of an antiseptic wash on affected areas is recommended.
Crohn's Disease (Adults)
Standard induction: 80 mg initially, then 40 mg two weeks later.
Rapid induction (if needed): 160 mg at week 0, then 80 mg at week 2.
Maintenance: 40 mg every other week. May be increased to 40 mg weekly or 80 mg every other week based on response.
Ulcerative Colitis (Adults)
Induction: 160 mg at week 0, then 80 mg at week 2.
Maintenance: 40 mg every other week. May be increased to 40 mg weekly or 80 mg every other week based on response.
Non-Infectious Uveitis (Adults)
Loading dose: 80 mg (two 40 mg injections on the same day).
Maintenance: 40 mg every other week, starting one week after the loading dose.
Corticosteroids or other immunomodulatory agents may be continued alongside AMGEVITA.
Paediatric Dosing
| Condition | Age / Weight | Dose | Frequency |
|---|---|---|---|
| Polyarticular JIA / Enthesitis-related arthritis | ≥2 years (≥30 kg) | 40 mg | Every other week |
| Plaque psoriasis | 4-17 years (≥30 kg) | 40 mg loading, then 40 mg | Every other week |
| Hidradenitis suppurativa | 12-17 years (≥30 kg) | 80 mg loading, then 40 mg | Every other week (may increase) |
| Crohn's disease | 6-17 years (<40 kg) | 40 mg loading, then 20 mg | Every other week |
| Crohn's disease | 6-17 years (≥40 kg) | 80 mg loading, then 40 mg | Every other week |
| Ulcerative colitis | 6+ years (<40 kg) | 80 mg loading, then 40 mg | Every other week |
| Ulcerative colitis | 6+ years (≥40 kg) | 160 mg loading, then 80 mg | Every other week |
| Non-infectious anterior uveitis | ≥2 years (≥30 kg) | 40 mg (with methotrexate) | Every other week |
| Non-infectious anterior uveitis | ≥2 years (<30 kg) | 20 mg (with methotrexate) | Every other week |
Elderly Patients
No dose adjustment is required in elderly patients. However, patients over 65 years should be monitored more carefully for signs of infection, as they may be more susceptible to infections during treatment. Your doctor will evaluate the benefit-risk balance individually.
Missed Dose
If you forget to inject AMGEVITA, administer the dose as soon as you remember. Then take your next dose on the originally scheduled day as if you had not missed a dose. Do not inject a double dose to make up for a missed one.
Overdose
If you accidentally inject AMGEVITA more often than prescribed, contact your doctor or pharmacist and inform them that you have taken too much. Always bring the outer carton of the medicine with you, even if it is empty. No dose-limiting toxicity has been identified in clinical trials at doses up to 10 mg/kg, but medical supervision is recommended after any overdose.
Stopping Treatment
The decision to stop using AMGEVITA should be discussed with your doctor. Your symptoms may return once treatment is discontinued. Do not stop treatment on your own without medical advice, as disease flares can occur.
How to Inject AMGEVITA
AMGEVITA is administered via subcutaneous injection using the SureClick pre-filled pen. It should not be injected into areas that are tender, bruised, red, or hard. Rotate injection sites between the thigh and abdomen (avoiding 5 cm around the navel). Allow the pen to reach room temperature (15-30 minutes) before injecting. Follow these key steps:
- Remove the pen from the refrigerator and let it warm to room temperature for 15-30 minutes.
- Check that the solution is clear and colourless to slightly yellow. Do not use if cloudy or discoloured.
- Clean the injection site with an alcohol swab and allow the skin to dry.
- Pull the yellow cap straight off. Do not twist or bend it.
- Stretch or pinch the skin at the injection site. Place the pen at 90 degrees against the skin and press down firmly.
- Press the blue start button. Hold for about 10 seconds until the window turns yellow.
- Dispose of the used pen in a sharps container. Apply a plaster if needed.
What Are the Side Effects of AMGEVITA?
Quick Answer: The most common side effects include injection site reactions, respiratory infections, headache, abdominal pain, nausea, rash, and musculoskeletal pain. Serious but less common side effects include serious infections (including TB), certain cancers, heart failure, and demyelinating diseases. Side effects can appear up to 4 months after the last injection.
Like all medicines, AMGEVITA can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some can be serious and require medical attention. Side effects may occur up to 4 months after the last injection.
- Severe itching, hives, or other signs of allergic reaction
- Swollen face, hands, or feet
- Difficulty breathing or swallowing
- Shortness of breath when lying down or swollen feet (signs of heart failure)
Very Common
May affect more than 1 in 10 people
- Injection site reactions (pain, swelling, redness, itching)
- Respiratory tract infections (cold, runny nose, sinusitis, pneumonia)
- Headache
- Abdominal pain, nausea and vomiting
- Skin rash
- Musculoskeletal pain (muscle, bone and joint pain)
- Low white blood cell count, low red blood cell count
- Raised blood lipids, elevated liver enzymes
Common
May affect up to 1 in 10 people
- Serious infections (sepsis, influenza)
- Intestinal infections (gastroenteritis)
- Skin infections (cellulitis, shingles), oral infections (cold sores)
- Ear, urinary tract, genital, and fungal infections
- Skin cancer (non-melanoma), benign tumours
- Mood changes (depression), anxiety, insomnia
- Sensory disturbances (tingling, numbness), migraine
- Eye inflammation, blurred vision, dry eyes
- Dizziness (vertigo), rapid heartbeat, high blood pressure
- Cough, asthma, shortness of breath
- Gastrointestinal bleeding, dyspepsia, acid reflux
- Itching, eczema, bruising, hair loss, increased sweating
- New onset or worsening of psoriasis
- Muscle spasms, blood in urine, kidney problems
- Chest pain, oedema (fluid retention), fever
- Low platelet count, impaired healing
Uncommon
May affect up to 1 in 100 people
- Opportunistic infections (including tuberculosis)
- Neurological infections (viral meningitis)
- Cancer including lymphoma and melanoma
- Sarcoidosis, vasculitis (inflammation of blood vessels)
- Tremor, neuropathy, stroke
- Hearing loss, tinnitus
- Heart attack, irregular heartbeat, heart failure symptoms
- Aortic aneurysm, deep vein thrombosis, pulmonary embolism
- Interstitial lung disease, pleural effusion
- Pancreatitis, difficulty swallowing, gallbladder inflammation
- Fatty liver, night sweats
- Lupus-like syndrome, sleep disturbances
Rare
May affect up to 1 in 1,000 people
- Leukaemia (cancer affecting blood and bone marrow)
- Severe allergic reaction with shock (anaphylaxis)
- Multiple sclerosis, Guillain-Barré syndrome
- Cardiac arrest, pulmonary fibrosis
- Intestinal perforation
- Hepatitis (liver inflammation), reactivation of hepatitis B
- Autoimmune hepatitis
- Stevens-Johnson syndrome (life-threatening skin reaction)
- Cutaneous vasculitis, erythema multiforme
- Angioedema (localised skin swelling)
- Pancytopenia (low counts of all blood cells)
Some side effects of AMGEVITA may not cause noticeable symptoms and can only be detected through routine blood work. These include changes in white blood cell counts, red blood cell counts, platelet counts, liver enzymes, blood lipids, uric acid, calcium, phosphate, sodium, potassium, and blood sugar levels. Your doctor will schedule regular blood tests to monitor these parameters throughout your treatment.
Reporting Side Effects: If you experience any side effects, including possible side effects not listed here, talk to your doctor or pharmacist. You can also report side effects directly through your national pharmacovigilance reporting system (e.g., the Yellow Card scheme in the UK, MedWatch in the US, or the EMA adverse reaction reporting portal in the EU). Reporting helps monitor the benefit-risk balance of medicines.
How Should You Store AMGEVITA?
Quick Answer: Store AMGEVITA in a refrigerator at 2-8°C. Do not freeze. Keep in the original packaging to protect from light. A single pen can be stored at room temperature (up to 25°C) for a maximum of 14 days if protected from light.
Keep this medicine out of the sight and reach of children. Do not use AMGEVITA after the expiry date stated on the label and carton (EXP). The expiry date refers to the last day of that month.
- Refrigerated storage: 2°C to 8°C (36°F to 46°F)
- Do not freeze. If accidentally frozen, do not use the pen.
- Protect from light: Store in original packaging at all times.
- Room temperature option: Up to 25°C (77°F) for a single period of maximum 14 days, protected from light. Discard if not used within 14 days.
- Do not return a pen to the refrigerator once it has been stored at room temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment. Used pre-filled pens and sharps should be disposed of in an approved sharps disposal container.
What Does AMGEVITA Contain?
Quick Answer: Each AMGEVITA pre-filled pen contains 40 mg of adalimumab in 0.8 ml of solution. The solution is clear and colourless to slightly yellowish. Inactive ingredients include glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide, and water for injections. AMGEVITA contains less than 1 mmol sodium per dose.
The active substance is adalimumab. Each pre-filled SureClick pen contains 40 mg of adalimumab in 0.8 ml of solution.
The other ingredients (excipients) are:
- Glacial acetic acid
- Sucrose
- Polysorbate 80
- Sodium hydroxide (for pH adjustment)
- Water for injections
Sodium content: This medicine contains less than 1 mmol (23 mg) of sodium per 0.8 ml dose, meaning it is essentially sodium-free.
Appearance: AMGEVITA is a clear and colourless to slightly yellowish solution. Each pack contains one, two, four, or six single-use SureClick pre-filled pens.
Marketing Authorisation Holder and Manufacturer: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Netherlands.
Frequently Asked Questions About AMGEVITA
AMGEVITA is used to treat several inflammatory and autoimmune conditions. These include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, ankylosing spondylitis, axial spondyloarthritis, psoriatic arthritis, plaque psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis, and non-infectious uveitis. It works by blocking TNF-alpha, a key inflammatory protein in the body.
AMGEVITA is a biosimilar to Humira, meaning it contains the same active substance (adalimumab) and has been shown to be equivalent in quality, efficacy, and safety through rigorous clinical testing. It is approved for the same indications and can typically be used interchangeably. Biosimilars undergo a thorough regulatory evaluation before approval by agencies such as the EMA and FDA.
The most common dosing schedule is 40 mg injected under the skin every two weeks. However, some conditions may require initial loading doses (higher doses at the start of treatment) and some patients may need weekly dosing if the standard dose provides insufficient response. Your doctor will determine the appropriate frequency for your specific condition.
The most common side effects (affecting more than 1 in 10 people) include injection site reactions such as pain, redness, or swelling; upper respiratory tract infections like colds and sinusitis; headache; stomach pain; nausea; skin rash; and muscle or joint pain. Most of these side effects are mild and manageable. However, if you experience signs of serious infection or allergic reaction, you should contact your doctor immediately.
There is no specific contraindication against moderate alcohol consumption with AMGEVITA. However, both adalimumab and alcohol can affect the liver. If you are also taking methotrexate (which has hepatotoxic potential), alcohol consumption should be discussed carefully with your doctor. Excessive alcohol intake should generally be avoided as it may worsen your underlying condition and overall health.
AMGEVITA should be refrigerated at 2-8°C and kept in its original packaging to protect from light. Do not freeze. If necessary, one pen may be kept at room temperature (up to 25°C) for up to 14 days. Once stored at room temperature, do not return it to the refrigerator, and discard it if not used within 14 days.
References
This article is based on the following peer-reviewed sources and international medical guidelines:
- European Medicines Agency (EMA). AMGEVITA Summary of Product Characteristics (SmPC). EMA/EPAR. Updated 2025. Available at: ema.europa.eu/amgevita
- U.S. Food and Drug Administration (FDA). Adalimumab Biosimilar Products. FDA Drugs Database. 2025.
- Smolen JS, Landewé RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82(1):3-18. doi:10.1136/ard-2022-223356
- Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn's disease. Lancet. 2017;389(10080):1741-1755. doi:10.1016/S0140-6736(16)31711-1
- National Institute for Health and Care Excellence (NICE). Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis. Technology appraisal guidance [TA715]. 2021.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List (2023). Geneva: WHO; 2023.
- British National Formulary (BNF). Adalimumab. NICE BNF. Updated 2025.
- Cohen SB, Alonso-Ruiz A, Engel T, et al. Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis. Ann Rheum Dis. 2018;77(6):914-921.
- Jorgensen KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389(10086):2304-2316.
- American College of Rheumatology (ACR). 2021 American College of Rheumatology Guideline for Treatment of Rheumatoid Arthritis. Arthritis Care Res. 2021;73(7):924-939.
Editorial Team
This article has been written and reviewed by iMedic's medical editorial team, consisting of licensed physicians specialising in clinical pharmacology, rheumatology, gastroenterology, and dermatology.
iMedic Medical Editorial Team
Specialists in Clinical Pharmacology and Internal Medicine
iMedic Medical Review Board
Independent review according to EMA, FDA, WHO and BNF guidelines
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