Pronunciation
go-LI-mu-mab

Trade Name(s)

• Simponi

Pregnancy Category
Category B

Ther. class.
antirheumatics

Pharm. class.
dmards
monoclonal antibodies
anti tnf agents

• Treatment of moderately to severely active rheumatoid arthritis (with methotrexate).

• Treatment of active psoriatic arthritis (alone or with methotrexate).

• Treatment of active ankylosing spondylitis.

Inhibits binding of TNF, to receptors inhibiting activity and resulting in anti-iflammatory and antiproliferative activity.

Therapeutic Effect(s):
Decreased pain and swelling with decreased joint destruction in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

Absorption: Well absorbed following subcutaneous administration.

Distribution: Distributed primarily in the circulatory system with limited extravascular distribution.

Metabolism and Excretion: Unknown.

Half-life: 2 wk.

TIME/ACTION PROFILE (improvement)

ROUTE	ONSET	PEAK	DURATION
Subcut	within 3 mo	2–7 days†	unknown

† Blood levels

Contraindicated in:

• Active infection (including localized);

• Concurrent use of abatacept or anakinra (↑ risk of infections);

• Lactation: Avoid during breastfeeding.

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;

• History of HF (may worsen);

• History of central nervous system demyelinating disorders (may worsen);

• History of cytopenias (may worsen);

• History of psoriasis (may exacerbate);

• Hepatitis B virus carriers (risk of reactivation);

• Geri: Use cautiously in elderly patients due to ↑ risk of infection;

• OB: Use during pregnancy only if clearly needed;

• Pedi: Safety not established; ↑ risk of lymphoma (including hepatosplenic T-cell lymphoma [HSTCL]), leukemia, and other malignancies.

CNS: CENTRAL NERVOUS SYSTEM DEMYELINATING DISORDERS.

EENT: nasopharyngitis.

Resp: upper respiratory tract infection.

CV: HF, hypertension.

GI: ↑ liver enzymes.

Derm: psoriasis.

Hemat: aplastic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia.

Local: injection site reactions.

Neuro: paresthesia.

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

*CAPITALS indicates life-threatening.
*italic indicates most frequent.

Drug-Drug

• Abatacept , anakinra , corticosteroids or methotrexate ↑ risk of serious infections; concurrent use with anakinra or abatacept is not recommended.

• ↓ antibody response and ↑ risk of adverse reactions with live virus vaccines .

• Concurrent use with azathioprine and/or methotrexate may ↑ risk of HSTCL.

• May normalize previously suppressed levels of CYP450 enzymes, following initiation or discontinuation of golimumab, effects of substrates of this system may be altered and should be monitored, including warfarin , theophylline , and cyclosporine .

• SC (Adults): 50 mg once monthly..

• Solution for subcutaneous injection: 50 mg/0.5 mL in single-dose prefilled syringes and Smartject autoinjectors

• Assess pain and range of motion before and periodically during therapy.

• Assess for signs and symptoms of infection (fever, dyspnea, flu-like symptoms, frequent or painful urination, redness or swelling at the site of a wound) prior to, during, and after therapy. Discontinue therapy if serious or opportunistic infection or sepsis occurs. If new infection develops during therapy, assess patient and institute antimicrobial therapy. Patients who tested negative for latent tuberculosis (TB) prior to therapy may develop TB during therapy. Initiate treatment for latent TB prior to initiating therapy.

• Monitor carriers of HBV for signs of reactivation during and for several months after therapy. If reactivation occurs, discontinue golimumab and institute antiviral therapy.

• Monitor patients with HF for new or worsening symptoms. Discontinue therapy if symptoms occur.

• Assess for exacerbations and new onset psoriasis. Discontinue therapy of these occur.

• Assess patient for latex allergy. Needle cover of syringe contains latex and should not be handled by persons sensitive to latex.

• Assess for signs and symptoms of systemic fungal infections (fever, malaise, weight loss, sweats, cough, dypsnea, pulmonary infiltrates, serious systemic illness with or without concomitant shock). Ascertain 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 the pathogens are identified. Consult with an infectious diseases specialist. Consider stopping golimumab until the infection has been diagnosed and adequately treated.

• Observe for signs and symptoms of anaphylaxis (rash, pruritus, laryngeal edema, wheezing). Discontinue drug and notify physician or other health care professional immediately if these problems occur. Keep epinephrine, an antihistamine, and resuscitation equipment close by in case of an anaphylactic reaction.

Lab Test Considerations

• Monitor liver function tests periodically during therapy. May cause ↑ serum AST and ALT.

» Monitor CBC with differential periodically during therapy. May cause leukopenia, neutropenia, thrombocytopenia, and pancytopenia. Discontinue golimumab if symptoms of blood dyscrasias (persistent fever) occur.

• Chronic pain (Indications)

• Risk for infection (Adverse Reaction)

• Administer a tuberculin skin test prior to administration of golimumab.

• Initial injection should be supervised by health care professional.

• Refrigerate solution; do not freeze. Allow prefilled syringe or auto-injector to sit at room temperature for 30 min prior to injection; do not warm in any other way. Do not shake. Solution is clear to slightly opalescent and colorless to light yellow. Do not administer solutions that are discolored, cloudy, or contain particulate matter. Discard unused solution.

• SC: Remove the needle cover or autoinjector cap just prior to injection. Inject into front of middle thigh, lower part of abdomen 2 inches from navel, or caregiver may administer into outer area of upper arm. Do not inject in areas where skin is tender, bruised, red, scaly, or hard; avoid scars or stretch marks. Press a cotton ball or gauze over injection site for 10 seconds; do not rub.

» Autoinjector: Press open end of autoinjector against skin at 90° angle. Use free hand to pinch and hold skin at injection site. Press button with fingers or thumb; button will stay pressed and does not need to be held. Injection will begin following a loud click. Keep holding the auto injector against skin until a second loud click is heard (usually 3–6 seconds, but may take up to 15 seconds). Lift autoinjector from skin following second click. Yellow indicator in viewing window indicates autoinjector worked correctly. If yellow does not appear in viewing window call 1-800-457-6399 for help.

» Prefilled syringe: Hold body of syringe between thumb and index finger. Do not pull back on plunger at any time. Pinch skin. Using a dart-like motion, insert needle into pinched skin at 45° angle. Inject all medication by pushing plunger until plunger head is between needle guard wings. Take needle out of skin and let go of skin. Slowly take thumb off plunger to allow empty syringe to move up until entire needle is covered by needle guard.

• Instruct patient on correct technique for administration. Review patient information sheet, preparation of dose, administration sites and technique, and disposal of equipment into a puncture-resistant container. Advise patient of risks and benefits of golimumab therapy. Inject missed doses as soon as remembered, then return to regular schedule. Instruct patient to read Medication Guide before starting therapy and with each Rx refill; new information may be available.

• Caution patient not to share this medication with others, even with the same symptoms; may be harmful.

• Inform patient of increased risk of infections, malignancies, cardiac and nervous system disorders during therapy.

• Caution patient to notify health care professional promptly if any signs of infection, including TB, invasive fungal infections (fever, malaise, weight loss, sweats, cough, dypsnea, pulmonary infiltrates, serious systemic illness with or without concomitant shock), reactivation of HBV, hypersensitivity reactions, or nervous system problems (vision changes, weakness in arms or legs, numbness or tingling in any part of the body) develop.

• 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.

• Inform patient to avoid receiving live vaccinations; other vaccinations may be given.

• Advise patient to notify health care professional of pregnancy is planned or suspected or if breastfeeding.

• Decreased pain and swelling with decreased rate of joint destruction in patients with rheumatoid arthritis.

• Decreased signs and symptoms, slowed progression of joint destruction, and improved physical function in patients with psoriatic arthritis.

• Reduced signs and symptoms of ankylosing spondylitis.