Hadlima dosage, forms, and strengths

Although Hadlima (adalimumab-bwwd) is a brand-name drug, it is a lower-cost alternative to Humira (adalimumab). Like Humira, Hadlima is every 2 week subcutaneous injection that reduces the symptoms of active inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, plaque psoriasis, uveitis, hidradenitis suppurativa, ulcerative colitis, and Crohn’s disease. The active ingredient in Hadlima is adalimumab-bwwd, a monoclonal antibody that is biosimilar to adalimumab, which is the active ingredient in Humira. Uses, dosages, therapeutic effects, and side effects are mostly identical between the two drugs. 

Hadlima forms and strengths

Although Hadlima comes in only one dosage form—subcutaneous (under the skin) injections—people can use either a pen autoinjector or prefilled syringe. Healthcare professionals use Hadlima vials for clinical injections. 

• Single-dose prefilled autoinjector: 40 mg/0.8 mL, 40 mg/0.4 mL

• Single-dose prefilled syringe: 40 mg/0.8 mL, 40 mg/0.4 mL

• Single-dose vial: 40 mg/0.8 mL

Hadlima dosage for adults

Like Humira, Hadlima is approved by the U.S. Food and Drug Administration (FDA) to reduce the symptoms and slow the damage of various inflammatory conditions, including inflammatory arthritis, inflammatory bowel disease, hidradenitis suppurativa, psoriasis, and noninfectious uveitis. Doses are injected every other week for most conditions, though exceptions are made for some patients with rheumatoid arthritis. 

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Hadlima dosage for inflammatory arthritis

Hadlima is used to reduce symptoms, slow down structural damage, and improve functioning in people with active rheumatoid arthritis (RA), ankylosing spondylitis (inflammatory arthritis of the spine), and psoriatic arthritis (PsA). Adalimumab, the active ingredient in Hadlima, belongs to a class of drugs called TNF inhibitors. These drugs block tumor necrosis factor (TNF), a protein that provokes immune system activity during flare-ups. 

• Standard Hadlima dosage for rheumatoid arthritis: 40 mg every other week. Some patients who are not on methotrexate may benefit from 40 mg once per week or 80 mg once every two weeks.

• Standard Hadlima dosage for ankylosing spondylitis or psoriatic arthritis: 40 mg once every two weeks

Hadlima dosage for inflammatory bowel disease (IBD)

Hadlima is used to control moderate to severe active inflammatory bowel disease. IBD includes two distinct conditions: ulcerative colitis and Crohn’s disease. Both are conditions in which the immune system attacks healthy cells in the colon, small intestines, and other parts of the digestive system. Crohn’s disease can be more serious and more extensive. Hadlima reduces IBD disease activity by blocking the TNF which plays an important role in spreading inflammation.. For ulcerative colitis, Hadlima is discontinued after eight weeks if there is no improvement. 

• Standard Hadlima dosage for inflammatory bowel disease: 160 mg on day one (or split into two 80 mg doses on the first two consecutive days), 80 mg on day 15, and then 40 mg once every two weeks starting on day 29

Hadlima dosage for plaque psoriasis

The FDA has approved Hadlima to treat moderate to severe chronic plaque psoriasis in adults who are candidates for oral or injectable drug therapy or phototherapy. As an inflammatory disease, psoriasis involves the immune system attacking healthy skin cells, producing thickened and discolored skin plaques. 

• Standard Hadlima dosage for rheumatoid arthritis: 80 mg starting dose on day one and then a 40 mg maintenance dose injected once every two weeks beginning on day eight

Hadlima dosage for hidradenitis suppurativa (acne inversa)

Hidradenitis suppurativa is, like psoriasis, an inflammatory disease of the skin. While psoriasis affects skin cells, hidradenitis suppurativa targets sweat glands, oil glands, and other tissues around hair follicles. Though not a true autoimmune disease, hidradenitis suppurativa is an inflammatory condition characterized by an immune overreaction to some other problem in the hair follicle. Flare-ups produce swelling, lumps, abscesses, pus drainage, and scarring, often in the armpits or groins. 

• Standard Hadlima standard dosage for moderate to severe hidradenitis suppurativa: 160 mg on day one (can be split into two 80 mg doses on the first two consecutive days), 80 mg on day 15, and then 40 mg once per week or 80 mg once every two weeks

Hadlima dosage for uveitis

Uveitis is inflammation of the middle layer of the eye, between the sclera (outer layer) and retina (inner layer). Infections often cause it, but it can also result from an immune system attack on the uveal tract (noninfectious uveitis). Hadlima is indicated for treating intermediate uveitis, posterior uveitis, and panuveitis.

• Standard Hadlima dosage for uveitis: 80 mg on day one and then 40 mg once every two weeks starting on day eight

Hadlima dosage for children

The FDA has approved Hadlima for juvenile idiopathic arthritis (JIA) in children 2 years of age or older and Crohn’s disease in children 6 and older. Juvenile idiopathic arthritis is similar to rheumatoid arthritis but afflicts pediatric patients and adolescents. Sometimes, many joints are affected, a condition called polyarticular juvenile idiopathic arthritis. Injections are given every other week, as in adult patients, but doses are based on body weight.

Hadlima dosage restrictions

Hadlima does not have any dosage restrictions or contraindications. However, because it weakens the immune system, people taking Hadlima are at a higher risk of serious infections, including serious bacterial, mycobacterial (tuberculosis), and fungal infections that can be associated with hospitalization and death. Your healthcare providerwill not start Hadlima in anyone with an active bacterial, viral, or fungal infection. Lymphoma and other malignancies, including non-melanoma skin cancer and leukemia, have been reported with TNF blockers, including adalimumab products. Other adverse effects include neurological reactions, hematological reactions, worsening of congestive heart failure, and lupus-like reactions.

The doctor will discontinue Hadlima in anyone who has a serious allergic reaction to the medicine or develops a lupus-like syndrome in response to Hadlima. 

How to take Hadlima

Hadlima is administered at home as a subcutaneous injection by the patient or a caregiver. A healthcare provider will demonstrate the proper procedure for giving injections and which skin areas to use.

Hadlima comes with a Medication Guide and Instructions for Use insert. Please read and follow the Instructions for Use and the FAQs when administering injections. The following instructions should not be considered a substitute for the Instructions for Use insert.

• Take Hadlima as instructed by the doctor and other healthcare providers.

• Keep track of where injections are given to ensure the next shot is given in a different spot. 

• Do not inject into skin areas that are red, bruised, tender, hard, or affected by psoriasis. 

• How to store Hadlima:

  • Store Hadlima in the refrigerator (36°F to 46°F) in its original package until it’s time for an injection. Do not freeze.

  • Remove the Hadlima autoinjector or prefilled syringe from the refrigerator 15 to 30 minutes before the injection to allow the medicine to come to room temperature.

  • Hadlima can be stored at room temperature for up to 14 days, provided the temperature does not exceed 77˚ F.

  • Do not drop, crush, or shake the carton or its contents.

• How to use the Hadlima PushTouch prefilled autoinjector:

  • Remove the autoinjector from the carton and inspect it. Follow the Instructions for Use for this inspection.

  • Wash and dry your hands.

  • Clean the injection area with an alcohol swab. Do not touch this area again until you are ready to inject the medicine.

  • Remove the clear needle cap from the autoinjector. Once removed, the cap should not be placed back on the needle.

  • Place the green base flat on the injection site at a 90˚angle to the skin.

  • Push the autoinjector down to start the injection. The autoinjector should click to signal the start of the injection.

  • Hold the base firmly against the skin until the yellow indicator completely fills the medicine window. The autoinjector should click a second time to signal that the injection is complete.

  • Pull the autoinjector straight up from the skin. The green base will automatically cover the needle.

  • Throw the autoinjector away in a sharps container.

• How to use Hadlima prefilled syringes:

  • Always hold the syringe by the plunger grip.

  • Remove the syringe from the carton and inspect it. Follow the Instructions for Use when inspecting the syringe.

  • Wash and dry your hands.

  • Choose a fatty area for the injection.

  • Clean the injection area with an alcohol swab. Do not touch this area again until you are ready to give an injection.

  • Remove the needle cap by pulling it straight off. Once removed, the cap should not be placed back on the needle. Do not touch the needle or allow it to touch anything.

  • Gently squeeze together the skin at the injection site. 

  • Holding the syringe by the barrel, insert the needle into the squeezed skin at a 45˚angle.

  • Slowly push the plunger down until the syringe is empty.

  • Take your thumb off the plunger. The needle will automatically retract into the barrel of the syringe.

  • Remove the needle. 

  • Throw the empty syringe away in a sharps container.

Hadlima dosage FAQs

How long does it take Hadlima to work?

Based on clinical trials, people taking Hadlima could experience significant symptom relief in two weeks to six months, depending on the condition being treated.

What happens if I miss a dose of Hadlima?

Take a missed dose as soon as it’s remembered. Take the next dose as scheduled.

How do I stop taking Hadlima?

Hadlima can be stopped at any time without causing withdrawal symptoms. The healthcare provider will discontinue Hadlima in anyone with a serious allergic reaction or lupus-like syndrome. Hadlima may need to be discontinued if there’s a worsening of congestive heart failure, neurological side effects including multiple sclerosis, optic neuritis, or Guillain-Barré syndrome.

What interacts with Hadlima?

Concomitant use of other immunosuppressants like methotrexate, azathioprine, steroids, JAK inhibitors, and biologics like Orencia (abatacept), and rituximab can increase the risk of serious infections.

Live vaccines should not be given to people on Hadlima, as they could cause a serious infection. 

Is it safe to take Hadlima during pregnancy?

Expectant mothers should ask the doctor for medical advice about the risks of taking Hadlima during pregnancy. Adalimumab crosses the placenta mainly during the third trimester and may alter the baby’s immune system.

Is it safe to take Hadlima while breastfeeding?

Hadlima should be safe to take while breastfeeding. What are the side effects of Hadlima?

The most common side effects of Hadlima are infections, headache, injection site reactions, and skin rash. 

What are the serious side effects of Hadlima?

The most serious adverse reactions to Hadlima are an increased risk of serious infections, reactivation of hepatitis B virus, tuberculosis, malignancies, skin cancer, lymphoma, and leukemia.

Sources

• Hadlima HCP, Organon

• Hadlima prescribing information, DailyMed (NIH National Library of Medicine)