Adalimumab: Uses, Indications, Dosages, Precautions, Contraindications, Side Effects & Interactions

Adalimumab

(a-da-lim-ue-mab)
Classification 
Pharmacotherapeutic: Monoclonal antibody
Clinical: Rheumatoid arthritis agent (disease modifying), immunomodulator, anti-TNF

Cyltezo

Humira

CATEGORY AND SCHEDULE

Pregnancy Risk Category: B

Do not confuse: Humira/Humulin/Humalog

General Information

Adalimumab belongs to the Monoclonal antibody group of rheumatoid arthritis agent (disease modifying), immunomodulator and anti-TNF. They are Reduces signs / symptoms, progression of structural damage, and improves physical function in adults with moderate to severe RA. It can be used alone or in combination with other disease-modifying antirheumatic drugs. First-line treatment of moderate to severe RA, treatment of psoriatic arthritis, treatment of ankylosing spondylitis, to induce / maintain remission of moderate to severe active Crohn's disease, moderate to severe plaque psoriasis in patients 6 years of age and older. Reduces the signs and symptoms of moderate to severe active polyarticular juvenile rheumatoid arthritis in patients 2 years of age and older. Treatment of active ulcerative colitis in patients unresponsive to immunosuppressants. Treatment of moderate to severe hidradenitis suppurativa. Treatment of uveitis (noninfectious intermediate, posterior and panuveitis) in adults

Adalimumab can cause severe reactions such as: Hypersensitivity reactions (rash, hives, hypotension, dyspnoea), infections (mainly upper respiratory tract, bronchitis, urinary tract) occur rarely. It can increase the risk of serious infections (pneumonia, tuberculosis, cellulitis, pyelonephritis, septic arthritis). It may increase the risk of hepatitis B virus reactivation in chronic carrier patients. It can cause a new onset or exacerbation of central nervous demyelinating disease; worsening and new–onset HF. It can increase the risk of malignant tumors (malignancies). Immunogenicity (anti-adalimumab autoantibodies) occurred in 12% of patients. TNF blockers are associated with an increased risk of secondary malignancies (lymphomas, skin cancers). Hepatosplenic T-cell lymphoma (HSTCL), a rare lymphoma, has been reported in young patients with inflammatory bowel disease

Action

A form of human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF); High levels of TNF are found in patients with rheumatoid arthritis

Therapeutic Effect

Decreases the signs / symptoms of RA, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis. It inhibits the progression of rheumatoid and psoriatic arthritis. Reduces epidermal thickness, inflammation of plaque psoriasis

Availability (Rx)

Pediatric Injection: 20 mg/0.4 mL in prefilled syringes

Injection: 40 mg/0.8 mL in prefilled syringes or prefilled pens

Uses

Reduction of signs and symptoms and inhibition of progression of structural damage in patients with moderate to severe active rheumatoid arthritis who are ≥ 18 years of age and who have not responded to other disease-modifying agents, juvenile rheumatoid arthritis (JRA), psoriatic arthritis, Crohn’s disease, moderate to severe plaque psoriasis, ankylosing spondylitis, ulcerative colitis

Precautions

Pregnancy B, breastfeeding, children, geriatric, CNS demyelinating disease,

lymphoma, latent TB, CHF, hepatitis B carriers, manitol hypersensitivity, latex allergy, neoplastic disease

Black Box Warning: Active infections, risk of lymphomas/leukemias, TB

Make sure to tell your doctor if:

• You have heart problems

• You have long-term hepatic or kidney problems

• You are taking other medicines

Indications and Dosages

‣ To Treat Rheumatoid arthritis, ankylosingspondylitis, psoriatic arthritis

• Adult: SUBCUT 40 mg every other wk or every week if not combined with methotrexate

‣ To Treat Juvenile rheumatoid arthritis (JRA)

• Child ≥ 4 yr/adolescent ≥ 30 kg: SUBCUT 40 mg every other wk

• Child ≥ 4 yr/adolescent ≥ 15 kg to < 30 kg: SUBCUT 20 mg every other wk

• Child ≥ 4 yr/adolescent < 15 kg: SUBCUT 24 mg/m2 BSA (up to 40 mg total) every other wk, then 20 mg every other wk

‣ To Treat Crohn’s diseasecurrent

• Adult: SUBCUT 160 mg given as 4 inj on day 1, or 2 inj on days 1 and 2, then 80 mg at wk 2 and 40 mg every other wk, starting at wk 4

‣ To Treat Plaque psoriasis

• Adult: SUBCUT 80 mg baseline as 2 inj, then 40 mg every other week starting 1 wk after initial dose ✖ 16 wk

‣ To Treat Ulcerative Colitis

• Adult, Elderly: SUBCUT Initially, 160 mg (4 injections in 1 day

or 2 injections over 2 days) then 80 mg 2 wks later (day 15), then 40 mg every

other wk beginning on day 29

‣ To Treat Hidradenitis Suppurativa

• Adult, Elderly: SUBCUT Initially, 160 mg (4 injections day 1) or

80 mg (2 injections on days 1 and 2), then 80 mg 2 wks later (day 15), then 40

mg weekly beginning day 29

‣ Dosage in Renal/Hepatic Impairment

• No dose adjustment

Pharmacokinetics

Time to peak serum concentration 131 h. Half-life: 10-20 days

Implementation

IV route

• Refrigerate; do not freeze

• Discard unused portion

• Rotate injection sites. Give new injection at least 1 inch from an old site and

never into area where skin is tender, bruised, red, or hard

• Give in thigh or lower abdomen

• Avoid areas within 2 inches of navel

Contraindications

Active infections

Cautions: Pts with chronic infections or pts at risk for infections

(e.g., diabetes, indwelling catheters, renal failure, open wounds), elderly,

decreased left ventricular function, HF, demyelinating disorders, invasive fungal

infections, history of malignancies

Interactions

Individual drugs

• Anakinra: do not use together, serious infections may occur

• Rilonacept: increase serious infections

Drug classifications

• Vaccines: do not give concurrently; immunization should be brought up to date before treatment

• Other TNF blockers: increased serious infections

Drug/laboratory tests

• May increase levels of blood cholesterol, other lipids, liver aminotransferases, creatine phosphokinase, and serum alkaline phosphatase

Drugs/food

• None known

Herbal

• Echinacea may decrease effects

Side effects

CNS: Confusion, fever, headache, hypertensive encephalopathy, multiple sclerosis,

paresthesia, subdural hematoma, syncope, tremor

CV: Arrhythmias, atrial fibrillation, cardiac arrest, chest pain, coronary artery disease, congestive heart failure, hypercholesterolemia, hyperlipidemia, hypertension, MI, palpitations, pericardial effusion, pericarditis, peripheral edema, tachycardia

EENT: Cataracts, sinusitis

ENDO: Ketosis, parathyroid disorder

GI: Abdominal pain, cholecystitis, cholelithiasis, diverticulitis, elevated alkaline

phosphatase level, elevated liver enzyme levels, esophagitis, gastroenteritis, hemorrhage, hepatic necrosis, nausea, vomiting

GU: Hematuria, paraproteinemia, pyelonephritis, UTI

HEME: Agranulocytosis, aplastic anemia, granulocytopenia, leukopenia, lymphocytosis, pancytopenia, polycythemia, thrombocytopenia

MS: Arthritis (including pyogenic or septic arthritis); back, extremity, pelvic, or thorax pain; bone disorder, fracture, or necrosis; muscle spasms; myasthenia; prosthetic infections; synovitis RESP: Asthma, bronchitis, bronchospasm, decreased pulmonary function, dyspnea, pleural effusion, pneumonia, pulmonary tuberculosis, upper respiratory tract infection

SKIN: Cellulitis, erysipelas, erythema multiforme, herpes zoster, new or worsening psoriasis, rash, urticaria

Other: Anaphylaxis; antibody formation against adalimumab; dehydration; flare-up of disease process; flulike symptoms; healing abnormalities; injection site erythema, hemorrhage, itching, pain, or swelling; invasive fungal infection; lupus-like symptoms; lymphomas; malignancies; opportunistic infection; postsurgical infection; sepsis; tuberculosis (miliary, lymphatic, or peritoneal)

 

Nursing considerations

Baseline assessment

• Assess onset, type, location, duration of pain or inflammation

• Inspect appearance of affected joints for immobility, deformities, skin condition. Review immunization status/screening for TB. If pt is to self-administer, instruct on subcutaneous injection technique, including areas of the body acceptable for

injection sites

Intervention/evaluation

• Monitor lab values, particularly CBC

• Assess for therapeutic response: relief of pain, stiffness, swelling; increased joint mobility; reduced joint tenderness; improved grip strength

Equipment must be available for anaphylaxis

• Rheumatoid arthritis: assess for pain, stiffness, ROM, swelling of joints during treatment

• Check for inj site pain, swelling, redness; usually occur after 2 inj (4-5 days) use cold compress to relieve pain/swelling

• May reactivate hepatitis B in chronic carriers, may be fatal

• Assess for anaphylaxis, latex allergic; stop therapy if lupuslike syndrome develops

• Assess for blood dyscrasias: CBC, differential periodically

Evaluation

Positive therapeutic result

• Decreased inflammation, pain in joints, decreased joint destruction

Patient/family teaching

• Instruct patient to that injection site reaction generally occurs in first month of treatment and decreases in frequency during continued therapy

• Teach patient about self-administration if appropriate: inj should be made in thigh, abdomen, upper arm; rotate sites at least 1 inch from old site; do not inject in areas that are bruised, red, hard

• Advise patient that if medication is not taken when due, inject next dose as soon as remembered and inject next dose as scheduled

• Advise patient not to take any live-virus vaccines during treatment

• Instruct patient to report signs of infection, allergic reactions, rash, nausea, lupuslike syndrome, immediately