Humira (Adalimumab)

Humira
Adalimumab
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Description

Humira is a brand-name medication that acts as a TNF blocker that lowers your immune system’s ability to fight infections.

By targeting and blocking a source of inflammation caused by moderate to severe Crohn’s disease, Humira can help many adults achieve and maintain remission.

The Food and Drug Administration (FDA) has approved biosimilar versions (biosimilars are similar or exact copies of a brand-name drug) of Humira such as Abrilada, Amjevita, Cyltezo, Hadlima, and Hyrimoz.

The active drug in Humira is called adalimumab.

The injection is administered by injection under the skin. You can distribute it yourself in the comfort of your own home, either by a Pen or a prefilled syringe.

Warnings and Precautions

Before using Humira, inform your doctor if you have any allergies. This medication may contain ingredients such as latex or natural rubber that may trigger an allergic reaction. Consult your pharmacist as well.

Before starting Humira, inform your doctor of your medical histories such as recent/current/repeated infections such as TB infection, histoplasmosis or hepatitis B; blood bone marries problems (such as low white/red blood cells or platelets), certain brain/nerve disorders (such as MS, Guillain-Barre syndrome), heart disease, cancer, diabetes or lupus.

Wash your hands thoroughly to prevent the spread of infections. Humira may increase your chances of getting infections or worsening conditions. Inform your doctor if you have been exposed to an infection and avoid contact with people with measles, chickenpox, or have the flu.

Consult your doctor if you are looking to get any vaccinations or immunizations, and avoid people who have recently received vaccinations.

Be attentive when using sharp objects such as razors and nail cutters to avoid getting cut, bruised, or injured. Avoid contact sports.

Inform your doctor about all medications you are currently taking, including over-the-counter drugs, herbal supplements, and other prescription medications.

Let your doctor know if you plan on getting pregnant or pregnant if you are using or planning to use Humira. Humira should only be used if needed during pregnancy. Speak to your doctor about the risks and benefits of taking Humira.

Since this medication passes through breast milk, you should consult your doctor before breastfeeding.

Older adults are at an increased risk of infections while using this medication.

Usage

Humira is a tumor necrosis factor (TNF) blocker indicated for the treatment of

• Rheumatoid Arthritis: Reducing signs and symptoms, inducing primary clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.

• Juvenile Idiopathic Arthritis: Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients two years of age and older.

• Psoriatic Arthritis: Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.

• Ankylosing Spondylitis: Reducing signs and symptoms in adult patients with active AS.

• Adult Crohn’s Disease: Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.

• Pediatric Crohn’s Disease: Reducing signs and symptoms and inducing and maintaining clinical remission in patients six years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.

• Ulcerative Colitis: Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine, or 6-mercaptopurine (6-MP). The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.

• Plaque Psoriasis: The treatment of adult patients with moderate to severe chronic plaque psoriasis candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

• Hidradenitis Suppurativa: The treatment of moderate to severe hidradenitis suppurativa.

• Uveitis: The treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

Side Effects

If you experience severe side effects related to taking Humira, consult your doctor immediately. If you feel the symptoms are life-threatening, seek a medical emergency by calling 911.

Serious side effects experienced by patients taking Humira include heart failure, which has the symptoms of sudden weight gain, shortness of breath, swelling of feet and ankles.

Another severe side effect is Lupis-like syndrome which may have the symptoms of shortness of breath, joint pain, discomfort or pain in the chest, and rashes on arms and chest that worsen in the sun.

Nerve disorders or demyelinating diseases such as multiple sclerosis or seizures are also possible side effects.  The symptoms include vision problems, dizziness, tingling or numbness, weakness in the arms or legs.

Blood disorders such as anemia should also be monitored. They have the symptoms of bleeding, bruising, the appearance of pale skin, and long-lasting fevers.

This medication has also been linked to liver damage. The symptoms of liver damage include stomach ache, loss of appetite, vomiting, and jaundice.

Pregnancy

Available studies using adalimumab during pregnancy do not reliably establish an association between adalimumab and significant congenital disabilities.

Clinical data are available from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Humira Pregnancy Registry in pregnant women with rheumatoid arthritis (RA) or Crohn’s disease (CD). Registry results showed a rate of 10% for significant congenital disabilities with first-trimester use of adalimumab in pregnant women with RA or CD and 7.5% for significant congenital disabilities in the disease-matched comparison cohort.

The lack of pattern of significant congenital disabilities is reassuring, and differences between exposure groups may have impacted the occurrence of congenital disabilities. Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant. In an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (MRHD) of 40 mg subcutaneous without methotrexate (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Storage

Humira must be kept cold and stored in the refrigerator. It is delivered in an insulated container to maintain its integrity.

Please keep it in its original packaging until ready for use.

Do not freeze or ever use if it was previously frozen.

Keep the medication away from direct sunlight.

When ready to use, take it out of the refrigerator and let it naturally warm up. Do not try to warm it up faster.

When traveling or not able to keep medication cold, Humira can be stored at room temperature (up to 77 degrees) for up to 2 weeks. Humira can be retained unrefrigerated for up to 14 days. If it exceeds two weeks or this temperature, d not use.

When disposing of medication, do not flush down wastewater (i.e., toilet or sink) or put it in household trash. Discard this medication according to your pharmacist’s instructions when expired or no longer needed.