golimumab

REMS

Simponi and Simponi Aria

Treatment of the following conditions:
- Moderately to severely active rheumatoid arthritis (in combination with methotrexate),
- Active psoriatic arthritis,
- Active ankylosing spondylitis.

Simponi

Moderately to severely active ulcerative colitis in patients who have demonstrated corticosteroid dependence or have responded inadequately to immunosuppressants such as aminosalicylates, corticosteroids, azathioprine, or 6–mercaptopurine.

Simponi Aria

Active polyarticular juvenile idiopathic arthritis.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Active infection (including localized);
Concurrent use of abatacept or anakinra (↑ risk of infections).

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);
Pre-existing CNS demyelinating disorders (including multiple sclerosis or Guillain-Barré syndrome);
History of cytopenias (may worsen);
History of psoriasis (may exacerbate);
Hepatitis B virus carriers (risk of reactivation);
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: Safety and effectiveness not established in children <18 yr (rheumatoid arthritis, ankylosing spondylitis, or ulcerative colitis) or <2 yr (psoriatic arthritis or polyarticular juvenile idiopathic arthritis); ↑ risk of lymphoma (including HSTCL), leukemia, and other malignancies in children;
Geri: ↑risk of infection in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

CV: HF, hypertension

Derm: psoriasis

EENT: nasopharyngitis, optic neuritis

GI: ↑liver enzymes

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

Local: injection site reactions

Neuro: CENTRAL NERVOUS SYSTEM DEMYELINATING DISORDERS, Guillain-Barre syndrome, multiple sclerosis, paresthesia

Resp: upper respiratory tract infection

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

Interactions ⬆ ⬇

Drug-drug:

Abatacept, anakinra, corticosteroids, or methotrexate↑ risk of serious infections; concurrent use with anakinra or abatacept is not recommended.
Use of live virus vaccines or therapeutic infectious agents may ↑ risk of infection; avoid concurrent use.
Concurrent use with azathioprine and/or 6–mercaptopurine 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.

Availability ⬆ ⬇

Solution for SUBQ injection (prefilled syringes and autoinjectors): 50 mg/0.5 mL; 100 mg/mL
Solution for intravenous injection (Simponi Aria): 12.5 mg/mL

Route/Dosage ⬆ ⬇

Rheumatoid Arthritis and Ankylosing Spondylitis

SC (Adults ): 50 mg once monthly.
IV (Adults ): 2 mg/kg initially and 4 wk later, then 2 mg/kg every 8 wk.

Psoriatic Arthritis

SC (Adults ): 50 mg once monthly.
IV (Adults ): 2 mg/kg initially and 4 wk later, then 2 mg/kg every 8 wk.
IV (Children ≥2 yr): 80 mg/m² initially and 4 wk later, then 80 mg/m² every 8 wk.

Ulcerative Colitis

SC (Adults ): 200 mg initially, then 100 mg 2 wk later, then 100 mg every 4 wk.

Polyarticular Juvenile Idiopathic Arthritis

IV (Children ≥2 yr): 80 mg/m² initially and 4 wk later, then 80 mg/m² every 8 wk.

US Brand Names ⬆ ⬇

Simponi, Simponi Aria

Action ⬆ ⬇

Inhibits binding of TNFα to receptors inhibiting activity and resulting in anti-inflammatory and antiproliferative activity.

Therapeutic effects:

Decreased pain and swelling with decreased joint destruction in patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis.
Induction and maintenance of clinical remission of ulcerative colitis.

Classifications ⬆ ⬇

Therapeutic Classification: antirheumatics

Pharmacologic Classification: dmards, monoclonal antibodies, anti tnf agents

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following SUBQ administration. IV administration results in complete bioavailability.

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

Metabolism/Excretion: Unknown.

Half-Life: 2 wk.

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

(improvement)

ROUTE	ONSET	PEAK	DURATION
SUBQ	within 3 mo	2–7 days‡	unknown
IV	within 3 mo	unknown	unknown

‡Blood levels.

Patient/Family Teaching ⬆ ⬇

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, dyspnea, pulmonary infiltrates, serious systemic illness with or without concomitant shock), reactivation of 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), 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 examine skin periodically during therapy and notify health care professional of any changes in appearance of skin or growths on skin.
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.
Inform patient of increased risk of cancer. Advise patient of need for screening for dysplasia (colonoscopy, skin cancer examinations, biopsy) periodically during therapy.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Advise females to notify health care professional if they recently had a baby while taking golimumab. Infants have an increased chance of getting an infection for up to 6 mo after birth; avoid administration of live vaccines to infants for 6 mo after mother's last dose.

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Indications ⬇