adalimumab

REMS

Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Humira, Idacio, Hyrimoz, Simlandi, Yuflyma, and Yusimry

Treatment of the following conditions:
- Moderately to severely active rheumatoid arthritis (may be used alone or with methotrexate or other non-biologic disease-modifying antirheumatic drugs [DMARDs]);
- Psoriatic arthritis (may be used alone or with other non-biologic DMARDs);
- Active ankylosing spondylitis;
- Moderately to severely active Crohn's disease in patients who have responded inadequately to conventional therapy;
- Moderately to severely active ulcerative colitis in patients who have responded inadequately to immunosuppressants such as corticosteroids, azathioprine, or 6-mercaptopurine;
- Moderate to severely active polyarticular juvenile idiopathic arthritis (as monotherapy or with methotrexate);
- Moderate to severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy and when other systemic therapies are deemed inappropriate;
- Noninfectious intermediate, posterior and panuveitis.

Abrilada, Amjevita, Cyltezo, Hadlima, Humira, Hyrimoz, Idacio, Simlandi, Yuflyma, and Yusimry only

Treatment of the following condition:
- Moderate to severe hidradenitis suppurativa.

Action ⬆ ⬇

Neutralizes and prevents the action of tumor necrosis factor (TNF), resulting in anti-inflammatory and antiproliferative activity.

Therapeutic effects:

Decreased pain and swelling with decreased rate of joint destruction in patients with rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, and ankylosing spondylitis.
Reduced signs and symptoms and maintenance of clinical remission of Crohn's disease.
Induction and maintenance of clinical remission of ulcerative colitis.
Reduced severity of plaques.
Reduced number of abscesses and inflammatory nodules.
Decreased progression of uveitis.

Pharmacokinetics ⬆ ⬇

Absorption: 64% absorbed after SUBQ administration.

Distribution: Synovial fluid concentrations are 31–96% of serum.

Metabolism/Excretion: Unknown.

Half-Life: 14 days (range 10–20 days).

Time/Action Profile ⬆ ⬇

(improvement)

ROUTE	ONSET	PEAK	DURATION
SUBQ	8–26 wk	131 hr*	2 wk‡

*Plasma concentration.

‡Following discontinuation.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Concurrent use of anakinra or abatacept;
Active infection (including localized).

Use Cautiously in:

History of chronic or recurrent infection or underlying illness/treatment predisposing to infection;
History of exposure to tuberculosis;
History of opportunistic infection;
Patients residing, or who have resided, where tuberculosis, histoplasmosis, coccidioidomycoses, or blastomycosis is endemic;
Pre-existing or recent-onset CNS demyelinating disorders;
History of lymphoma;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Children <2 yr (safety not established); ↑ risk of lymphoma (including hepatosplenic T-cell lymphoma [HSTCL] in patients with Crohn's disease or ulcerative colitis), leukemia, and other malignancies in children;
Geri: ↑risk of infection/malignancy in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypertension

Derm: rash, psoriasis

EENT: optic neuritis

GI: abdominal pain, nausea

GU: hematuria

Hemat: neutropenia, thrombocytopenia

Local: injection site reactions

Metab: hyperlipidemia

MS: back pain

Neuro: headache, Guillain-Barré syndrome, multiple sclerosis

Misc: fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), INFECTION (INCLUDING REACTIVATION TUBERCULOSIS [TB] AND OTHER OPPORTUNISTIC INFECTIONS DUE TO BACTERIAL, INVASIVE FUNGAL, VIRAL, MYCOBACTERIAL, AND PARASITIC PATHOGENS), MALIGNANCY (INCLUDING LYMPHOMA, HSTCL, LEUKEMIA, AND SKIN CANCER)

Interactions ⬆ ⬇

Drug-drug:

Concurrent use with anakinra, abatacept, or other TNF-blocking agents↑ risk of serious infections; concurrent use contraindicated.
Concurrent use with azathioprine and/or methotrexate may ↑ risk of HSTCL.
Live vaccinations should not be given concurrently. Risks and benefits should be considered before using live vaccinations in an infant exposed to adalimumab therapy in utero.

Route/Dosage ⬆ ⬇

Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis

SC (Adults ): 40 mg every other wk. Methotrexate, non-biologic DMARDs, corticosteroids, and/or analgesics may be continued during therapy. Patients not receiving concurrent methotrexate may receive additional benefit by ↑ dose to 40 mg once weekly or 80 mg every other wk.

Crohn's Disease

SC (Adults ): 160 mg initially on Day 1 (given in one day or over two consecutive days), followed by 80 mg 2 wk later on Day 15. Two wk later (Day 29), begin maintenance dose of 40 mg every other wk. Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g., azathioprine, 6-mercaptopurine, methotrexate) may be continued during therapy.
SC (Children ≥6 yr and ≥40 kg): Abrilada, Amjevita, Hadlima, Hulio, Humira, Hyrimoz, Idacio, and Simlandi only: 160 mg initially on Day 1 (given in one day or over two consecutive days), followed by 80 mg 2 wk later on Day 15. Two wk later (Day 29), begin maintenance dose of 40 mg every other wk. Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g., azathioprine, 6-mercaptopurine, methotrexate) may be continued during therapy.
SC (Children ≥6 yr and 17–<40 kg): Abrilada, Amjevita, Hadlima, Hulio, and Humira only: 80 mg initially on Day 1, followed by 40 mg 2 wk later on Day 15. Two wk later (Day 29), begin maintenance dose of 20 mg every other wk. Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g., azathioprine, 6-mercaptopurine, methotrexate) may be continued during therapy.

Ulcerative Colitis

SC (Adults ): 160 mg initially on Day 1 (given in one day or over two consecutive days), followed by 80 mg 2 wk later on Day 15. Two wk later (Day 29), begin maintenance dose of 40 mg every other wk. Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g., azathioprine, 6-mercaptopurine, methotrexate) may be continued during therapy. Should be continued only if patients have evidence of clinical remission by wk 8 of therapy.
SC (Children ≥5 yr and ≥40 kg): Humira only: 160 mg initially on Day 1 (given in one day or over two consecutive days), followed by 80 mg 1 wk later on Day 8, and then followed by 80 mg 1 wk later on Day 15. Two wk later (Day 29), begin maintenance dose of either 80 mg every other wk or 40 mg every wk. Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g., azathioprine, 6-mercaptopurine, methotrexate) may be continued during therapy.
SC (Children ≥5 yr and 20–<40 kg): Humira only: 80 mg initially on Day 1, followed by 40 mg 1 wk later on Day 8, and then followed by 40 mg 1 wk later on Day 15. Two wk later (Day 29), begin maintenance dose of either 40 mg every other wk or 20 mg every wk. Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g., azathioprine, 6-mercaptopurine, methotrexate) may be continued during therapy.

Juvenile Idiopathic Arthritis

SC (Children 2–17 yr (Abrilada, Amjevita, Hadlima, Hulio, Humira, Hyrimoz, Idacio, and Simlandi); 4–17 yr (Cyltezo): 10–<15 kg (Abrilada, Hadlima, Humira, and Hyrimoz only): 10 mg every other wk; 15–<30 kg (Abrilada, Amjeveta, Hadlima, Hulio, and Humira only): 20 mg every other wk; ≥30 kg: 40 mg every other wk.

Plaque Psoriasis

SC (Adults ): 80 mg initially; then in 1 wk, begin regimen of 40 mg every other wk.

Uveitis

SC (Adults ): 80 mg initially; then in 1 wk, begin regimen of 40 mg every other wk.
SC (Children ≥2 yr and ≥30 kg): Humira only: 40 mg every other wk.
SC (Children ≥2 yr and 15–<30 kg): Humira only: 20 mg every other wk.
SC (Children ≥2 yr and 10–<15 kg): Humira only: 10 mg every other wk.

Hidradenitis Suppurativa

SC (Adults ): Abrilada, Amjevita, Cyltezo, Hadlima, Humira, Hyrimoz, Idacio, Simlandi, Yuflyma, or Yusimry: 160 mg initially (given in one day or over two consecutive days), followed by 80 mg 2 wk later on Day 15. Two wk later (Day 29), begin maintenance dose of 40 mg every wk or 80 mg every other wk.
SC (Children ≥12 yr and ≥60 kg): Humira only: 160 mg initially (given in one day or over two consecutive days), followed by 80 mg 2 wk later on Day 15. Two wk later (Day 29), begin maintenance dose of 40 mg every wk or 80 mg every other wk.
SC (Children ≥12 yr and 30–59 kg): Humira only: 80 mg initially on Day 1, followed by 40 mg 1 wk later on Day 8. Two wk later (Day 22), begin maintenance dose of 40 mg every other wk.

Availability ⬆ ⬇

Solution for injection (prefilled syringes): 10 mg/0.1 mL; 10 mg/0.2 mL; 20 mg/0.2 mL; 20 mg/0.4 mL; 40 mg/0.4 mL; 40 mg/0.8 mL; 80 mg/0.8 mL
Solution for injection (vials): 40 mg/0.8 mL
Solution for injection (prefilled pens): 40 mg/0.4 mL; 40 mg/0.8 mL; 80 mg/0.8 mL

Assessment ⬆ ⬇

Assess for signs of infection (fever, dyspnea, flu-like symptoms, frequent or painful urination, redness or swelling at the site of a wound), including tuberculosis and hepatitis B virus (HBV), prior to and periodically during therapy. Adalimumab is contraindicated in patients with active infection. Monitor new infections closely; most common are upper respiratory tract infections, bronchitis, and urinary tract infections. Infections may be fatal, especially in patients taking immunosuppressive therapy.
Assess patient for latent tuberculosis with a tuberculin skin test prior to initiation of therapy. Start treatment of latent tuberculosis before therapy with adalimumab.
Monitor for injection site reactions (redness and/or itching, rash, hemorrhage, bruising, pain, or swelling). Rash will usually disappear within a few days. Application of a towel soaked in cold water may relieve pain or swelling.
Assess patient for latex allergy. Needle cover of syringe contains latex and should not be handled by persons sensitive to latex.
Monitor patient for signs of anaphylaxis (urticaria, dyspnea, facial edema) following injection. Medications (antihistamines, corticosteroids, epinephrine) and equipment should be readily available in the event of a severe reaction. Discontinue adalimumab immediately if anaphylaxis or other severe allergic reaction occurs.
Assess for signs and symptoms of systemic fungal infections (fever, malaise, weight loss, sweats, cough, dyspnea, pulmonary infiltrates, serious systemic illness with or without concomitant shock). Determine if patient lives in or has traveled to areas of endemic mycoses. Consider empiric antifungal treatment for patients at risk of histoplasmosis and other invasive fungal infections until pathogens are identified. Consult with an infectious diseases specialist. Consider stopping adalimumab until infection has been diagnosed and adequately treated.
Arthritis: Assess pain and range of motion before and periodically during therapy.
Crohn's Disease or Ulcerative Colitis: Monitor frequency and consistency of bowel movements periodically during therapy.
Plaque Psoriasis: Assess skin lesions periodically during therapy.
Hidradenitis Suppurativa: Monitor skin lesions (abscesses, inflammatory nodules, draining fistulas) during therapy.
Uveitis: Monitor signs and symptoms of uveitis (red eye with or without pain, photosensitivity, blurry vision, suddenly seeing "floaters") during therapy.

Lab Test Considerations:

Monitor CBC with differential periodically during therapy. May cause leukopenia, neutropenia, thrombocytopenia, and pancytopenia. Discontinue adalimumab if symptoms of blood dyscrasias (persistent fever) occur.
- Monitor for HBV blood tests before starting during, and for several mo after therapy is completed.

Implementation ⬆ ⬇

Administer a tuberculin skin test prior to administration of adalimumab. Patients with active latent TB should be treated for TB prior to therapy.
- Immunizations should be current prior to initiating therapy. Patients on adalimumab may receive concurrent vaccinations, except for live vaccines.
- Administer initial injection under supervision of a health care professional.
- Vial is for institutional use only. With training, patient may use pen and prefilled syringes at home.
- Do not administer solutions that are discolored or contain particulate matter. Discard unused solution.
SC: Solution may be left at room temperature for 15–30 min before injecting. Administer at a 45° angle in upper thighs or abdomen, avoiding the 2 inches around the navel. Put pressure on injection site for 10 sec; do not rub. Rotate injection sites; avoid areas that are tender, bruised, hard, or red. If multiple injections required per dose, administer in separate sites. Solution is clear to slightly opalescent, colorless to pale brownish-yellow; do not administer solutions that are cloudy, discolored, or contain particulate matter. Refrigerate prefilled syringes and pens.

Patient/Family Teaching ⬆ ⬇

Instruct patient on the correct technique for administering adalimumab. Review Medication Guide, preparation of dose, administration sites and technique, and disposal of equipment into a puncture-resistant container.
If a dose is missed, instruct patient to administer as soon as possible, then take next dose according to regular schedule.
Caution patient to notify health care professional immediately if signs of infection, HBV (muscle aches, clay-colored bowel movements, feeling very tired, fever, dark urine, chills, skin or eyes look yellow, stomach discomfort, little or no appetite, skin rash, vomiting), severe rash, swollen face, or difficulty breathing occurs or if nervous system problems (numbness or tingling, problems vision, weakness in arms or legs, dizziness) occur while taking adalimumab.
Inform patient that an increase risk of cancer occurs when taking adalimumab.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Instruct patient to notify health care professional of medication regimen prior to treatment or surgery.
Advise patient to avoid live vaccines during therapy.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Pen: Clean area for injection with alcohol swab. Hold pen with gray cap pointing up. Check solution through window; if discolored, cloudy, or contains flakes, discard solution. Turn pen over and point cap down to make sure solution reaches fill line; if not, do not use and contact pharmacist. Remove gray cap exposing the needle and the plum cap exposing the button; removing the plum cap activates the pen. Pinch skin and place pen, with window visible, against skin at a 90° angle and press button until a click is heard. Hold pen in place until all solution is injected (10 sec) and yellow marker is visible in window and has stopped moving. Continue to pinch skin throughout injection. Remove needle and press with a gauze pad or cotton ball for 10 sec. Do not rub injection site. Dispose of pen into a puncture-resistant container.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇