Hadlima is an injectable prescription medication containing the active ingredient adalimumab-bwwd. Made by the pharmaceutical company Organon, it is biosimilar to and interchangeable with Humira. This means that if a healthcare provider writes a prescription for Humira, the pharmacist may dispense Hadlima if allowed by state law. Hadlima is used to treat various autoimmune inflammatory conditions. Hadlima was FDA-approved in July 2019, and became available in the U.S. in July 2023.
Hadlima
N/A
Rheumatoid arthritis in adults
Juvenile idiopathic arthritis in pediatric patients 2 years and older
Psoriatic arthritis in adults
Ankylosing spondylitis in adults
Crohn’s disease in adults and children 6 years and older
Ulcerative colitis in adults
Plaque psoriasis in adults
Hidradenitis suppurativa in adults
Uveitis in adults
Tumor necrosis factor (TNF) blocker
Injectable
Subcutaneous (under the skin) injection of the thigh or abdomen
Hadlima is FDA approved to treat:
Rheumatoid arthritis in adults
Juvenile idiopathic arthritis in pediatric patients 2 years and older
Psoriatic arthritis in adults
Ankylosing spondylitis in adults
Crohn’s disease in adults and children 6 years and older
Ulcerative colitis in adults
Plaque psoriasis in adults
Hidradenitis suppurativa in adults
Uveitis in adults
Take Hadlima exactly as prescribed by your doctor. Be sure you understand how to use Hadlima before injecting it at home.
Your doctor will need to monitor your progress. Keep all appointments for your doctor as well as for bloodwork.
Rotate your injection site with each injection. Do not inject Hadlima into the same site two times in a row. Avoid injecting Hadlima into hard, red, swollen, or bruised skin—or skin with stretch marks or scars.
While taking Hadlima, avoid people who are sick or have an infection.
Avoid live vaccines when taking Hadlima. Ask your healthcare provider or pharmacist before getting any vaccines.
Auto-injector
40 milligrams (mg)/0.4 milliliters (mL)
40 mg/0.8 mL
Pre-filled syringe
40 mg/0.4 mL
40 mg/0.8 mL
Injection (vial)
40 mg/0.8 m
Adults with rheumatoid arthritis (RA), psoriatic arthritis, or ankylosing spondylitis: 40 mg every other week. Some individuals with RA may require a higher or more frequent dosage.
Pediatric patients with Crohn’s disease or juvenile idiopathic arthritis: dosage depends on weight
Adults with Crohn’s disease or ulcerative colitis: 160 mg on day 1 (given in one day or can be split over two consecutive days), 80 mg on day 15, and 40 mg every other week beginning on day 29.
Adults with plaque psoriasis or uveitis: 80 mg as an initial dose, then 40 mg every other week, beginning one week after the first dose
Hidradenitis suppurativa: 160 mg on day 1 (given in one day or can be split over two consecutive days), 80 mg on day 15, and 40 mg every week OR 80 mg every other week beginning on day 29.
Hadlima
0.8ml of 40mg/0.8ml syringe
Hadlima
2ml of 40mg/0.4ml syringe
Your healthcare provider will teach you and/or a caregiver or family member how to prepare and inject Hadlima. Do not try to inject Hadlima until you have been trained on how to use it.
Hadlima is given as a subcutaneous injection, under the skin of the thigh or abdomen.
Follow your healthcare provider’s instructions on how and when to inject Hadlima. Use Hadlima exactly as directed.
Prepare the injection when you are ready to administer it. Do not use the medication if it appears cloudy, has particles in it, or has changed colors. Call your pharmacist.
Your doctor will order blood tests before and while taking Hadlima.
Store Hadlima in the original container in the refrigerator, away from light. Do not freeze Hadlima.
Take the medicine out of the refrigerator about 30 minutes before using it, and let it come to room temperature. Do not try to warm it up yourself.
Do not reuse a needle or syringe. Discard a prefilled syringe or auto-injector after one injection, even if there is medicine still inside. Use a sharps container to dispose of used syringes and needles.
If you miss a dose of Hadlima, inject it as soon as you remember. Then, resume your next dose on the regularly scheduled day. However, if it is almost time for the next dose, skip the missed dose and resume your regular schedule. Do not take extra doses to try to make up for a missed dose. If you are not sure what to do, consult your healthcare provider.
You should not take Hadlima if you are allergic to Humira, adalimumab, or any ingredient in the medication.
You should not start taking Hadlima if you have an active infection.
Before taking Hadlima, tell your healthcare provider about all of your medical conditions. Let your doctor know if you are pregnant, planning to become pregnant, or breastfeeding.
Hadlima can cause serious complications, including:
Serious infections, including invasive fungal infections
Certain types of cancer
Serious allergic reactions
Reactivation of the hepatitis B virus (be alert to signs of liver problems, such as pain in the upper right side of the stomach, vomiting, appetite loss, fatigue, or yellowing of the skin or eyes)
Problems with the brain and spinal cord
Low blood cell counts
Heart failure
Lupus-like syndrome
Before taking Hadlima, tell your doctor about all the medications you take, including prescription and OTC drugs, vitamins, and supplements.
You should not take Hadlima in combination with Orencia (abatacept), Kineret (anakinra), or Rituxan (rituximab).
Hadlima should not be taken with other TNF blockers.
You should not get a live vaccine while taking Hadlima. Examples of live vaccines include measles, mumps, and rubella (MMR), varicella, rotavirus, and the nasal flu vaccine.
Other drugs that require close monitoring, such as Coumadin (warfarin), cyclosporine, or theophylline, may require additional monitoring and/or a dosage adjustment if taken with Hadlima.
If you have symptoms of an allergic reaction, seek emergency medical help. Symptoms may include hives, difficulty breathing or swallowing, or swelling of the face, lips, tongue, or throat.
Symptoms of a life-threatening skin reaction also require emergency medical help. Be alert to symptoms of fever, sore throat, burning eyes, skin pain, red or purple rash, or blistering or peeling skin.
Common side effects of Hadlima include:
Injection site reactions (redness, itching, swelling, bruising, or pain at the injection site)
Nausea
Back pain
Headache
Rash
Upper respiratory infections
Sinusitis
Serious side effects of Hadlima include:
Liver problems: upper stomach pain, appetite loss, fatigue, itching, dark urine, clay-colored stools, yellowing of the skin or whites of the eyes
Heart problems: swelling, shortness of breath, sudden weight gain
Lupus-like symptoms: muscle and/or joint pain, flulike symptoms, rash that gets worse in the sun
Nervous system problems such as numbness and tingling, dizziness, vision problems, weakness in the arms or legs
Tuberculosis: fever, cough, night sweats, appetite and weight loss, fatigue
This is not a full list of side effects and others may occur. Talk to your healthcare professional about potential side effects and what to do if you experience them.
Hadlima, National Library of Medicine, DailyMed (2023)
Adalimumab injection, MedlinePlus (2023)
After receiving her doctorate from the University of Pittsburgh School of Pharmacy, Karen Berger, Pharm.D., has worked in both chain and independent community pharmacies. She currently works at an independent pharmacy in New Jersey. Dr. Berger enjoys helping patients understand medical conditions and medications—both in person as a pharmacist, and online as a medical writer and reviewer.
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