Yuflyma

Indications

Adalimumab is a biologic medicine given by injection under the skin. It is used to treat long-term inflammatory diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis (inflammation of the spine), Crohn's disease, ulcerative colitis, moderate to severe plaque psoriasis, hidradenitis suppurativa (painful lumps in skin folds) and some types of uveitis (inflammation inside the eye). It is usually used when other treatments have not worked well enough.

How It Works

Adalimumab is a laboratory-made antibody that attaches to and blocks a protein called tumour necrosis factor alpha (TNF-alpha). In these diseases the immune system makes too much TNF-alpha, which drives inflammation, pain, swelling and tissue damage. Blocking it calms the inflammation, relieves symptoms and can slow damage to joints, gut and skin.

Dosage and Administration

Given as prescribed by a specialist doctor. It is injected under the skin of the thigh or abdomen, commonly every 1 or 2 weeks after a starting dose, depending on the condition. The first injection is given or supervised by a doctor or nurse; after training, patients or carers can inject at home. Rotate injection sites and do not inject into skin that is tender, bruised, red or hard. Let the pen or syringe reach room temperature for 15 to 30 minutes before use.

Interactions

• Do not use with other biologic medicines such as Anakinra or Abatacept, because of a high risk of serious infection.
• Live vaccines (such as BCG, oral polio, MMR, yellow fever) should not be given during treatment.
• It is often used with Methotrexate, which can improve its effect.
• Tell your doctor about all medicines, including other immune-suppressing drugs.

Contraindications

• Active tuberculosis (TB) or other severe infections, such as sepsis
• Moderate to severe heart failure
• Allergy to Adalimumab or any ingredient

Side Effects

• Injection site redness, itching, pain or swelling
• Upper respiratory infections, sinusitis, cold sores
• Headache, rash, nausea, stomach pain
• Raised liver enzymes
• Serious infections, including TB reactivation, fungal infections and hepatitis B reactivation
• Rarely, blood disorders, nerve problems, lupus-like illness or certain cancers such as lymphoma and skin cancer

Get urgent medical help if you develop fever, chills, persistent cough, night sweats or weight loss, signs of a serious allergic reaction (swelling of the face or throat, difficulty breathing), new or worsening breathlessness or leg swelling, unusual bruising or bleeding, yellow skin or eyes, numbness, weakness or vision changes.

Pregnancy and Lactation

Women who can become pregnant should discuss contraception with their doctor and continue it for at least 5 months after the last dose. Adalimumab may be continued in pregnancy if the specialist judges it necessary; babies exposed in the womb should not receive live vaccines (such as BCG) for 5 months after birth. Only small amounts pass into breast milk, and breastfeeding is usually considered acceptable after discussing with the doctor.

Precautions and Warnings

• You will be tested for TB and hepatitis B before starting.
• Tell your doctor promptly about any infection, and before surgery.
• Keep vaccines up to date before starting; avoid live vaccines during treatment.
• Use with care in heart failure, nerve diseases such as multiple sclerosis, and in people with a history of cancer.
• Have regular skin checks and use sun protection.

Overdose

No serious effects from overdose are known, but if more than the prescribed dose is injected, contact your doctor for advice and monitoring for infection.

Therapeutic Class

Biologic immunosuppressant, TNF-alpha inhibitor (monoclonal antibody)

Storage

Store in a refrigerator at 2 to 8°C, do not freeze, and keep in the original carton to protect from light. If needed, a pen or syringe may be kept at room temperature (up to 25°C) for a limited time stated on the pack. Keep out of the reach of children.