What Is Amgevita Used For?

Amgevita contains adalimumab and is a biosimilar medicine that has been assessed to be as safe and effective as the reference product. It works by treating inflammation in your body.

Primary Uses

Amgevita treats these inflammatory conditions: Ankylosing spondylitis, Crohn’s disease (adults and children 6+ years), Enthesitis-related arthritis, Hidradenitis suppurativa (adults and adolescents 12+ years), Polyarticular juvenile idiopathic arthritis, Psoriasis (adults and children 4+ years), Psoriatic arthritis, Rheumatoid arthritis, Ulcerative colitis, and Uveitis.

How to Take Amgevita

Amgevita is injected under the skin (subcutaneous). You should not attempt an injection until you have received proper training on the correct technique. The injection can be given by you, a family member, friend, or caregiver.

Dosage Instructions

Dosages vary by condition: Ankylosing spondylitis: 40 mg every fortnight. Crohn’s disease (adults): 160 mg on day 1, 80 mg on day 15, then 40 mg every fortnight. Rheumatoid arthritis: 40 mg every fortnight. Psoriasis (adults): 80 mg on day 1, 40 mg on day 8 and 22, then 40 mg every fortnight. Children’s doses are based on body weight. Your doctor may adjust your maintenance dose based on your response.

What If You Miss a Dose?

If you miss your dose, inject Amgevita as soon as you remember, then continue with your next dose at the usual scheduled time. It’s important to use your medicine as prescribed by your doctor.

Available Tablet Strengths

Side Effects

Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.

Common Side Effects

These side effects occur relatively frequently and usually don’t require emergency care:

• injection site reactions (pain, swelling, redness, itching)
• cold, flu, runny nose, cough, sore throat
• sinus infection, asthma worsening, bronchitis
• ear pain, eye pain or swelling, vision changes
• mouth ulcers, gum pain or bleeding
• headache, dizziness, muscle weakness
• joint pain, numbness, balance problems
• nausea, vomiting, stomach pain, heartburn
• rash, itching, scaly skin patches
• nail problems, hair loss, cold sores
• bleeding, bruising easily
• tiredness, chest pain, increased heart rate
• depression, anxiety

Important Warnings

There are several important conditions and situations where Amgevita should not be used or requires special caution.

Who Should Not Take Amgevita

Do not use Amgevita if you: are allergic to adalimumab or any ingredients, have a severe infection such as sepsis, tuberculosis, or other severe infections caused by virus, fungus, parasite or bacteria, or have moderate to severe heart failure as determined by your doctor.

Medical Conditions to Discuss

Check with your doctor if you have: scheduled vaccinations or surgery, lung disease (COPD), multiple sclerosis or similar nerve diseases, current or past hepatitis B, history of tuberculosis or close contact with someone who has it, recurring infections, fungal infections or travel to areas where they’re common, uveitis, allergic reactions, blood disorders, low resistance to disease, heart conditions, cancer, autoimmune disease, kidney or liver problems, psoriasis, or if you take phototherapy.

Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. Amgevita should only be used in pregnancy if clearly needed. If used during pregnancy, your baby may have higher risk of infection. Use effective contraception and continue for at least 5 months after your last injection. Tell your baby’s doctors if you used Amgevita during pregnancy, especially before vaccinations. Also inform your doctor if you are breastfeeding or plan to breastfeed.

Drug Interactions

Some medicines may interfere with Amgevita and affect how it works, or Amgevita may affect how other medicines work.

• anakinra (used for rheumatoid arthritis, juvenile idiopathic arthritis) – do not take together
• abatacept (used for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis) – increases infection risk
• azathioprine (immune system suppressor) – increases infection risk
• 6-mercaptopurine (used for certain types of leukemia) – increases infection risk

Alcohol & Driving

Be cautious with activities that require alertness until you know how Amgevita affects you.

Alcohol

There is no information available on the effects of taking Amgevita with alcohol.

Driving and Operating Machinery

Be careful before you drive or use any machines or tools until you know how Amgevita affects you. The effects on your ability to drive or use machines while taking Amgevita are not known.

Storage

Store Amgevita in the refrigerator at 2°C to 8°C. Do not freeze. Keep pens or syringes in the original pack to protect from light. When necessary, Amgevita may be stored at room temperature (25°C) for a maximum of 14 days, protected from light. Once removed from refrigerator, each pen or syringe must be used within 14 days or discarded, even if returned to refrigerator. Keep where children cannot reach it.

Overdose Information

If you think you have used too much Amgevita, you may need urgent medical attention. Immediately phone the Poisons Information Centre (13 11 26), contact your doctor, or go to the Emergency Department at your nearest hospital. Do this even if there are no signs of discomfort or poisoning. Always take the outer carton of the medicine with you.

Frequently Asked Questions