sarilumab

REMS

Moderately to severely active rheumatoid arthritis in patients who have not responded to ≥1 disease-modifying antirheumatic drugs (DMARD) (as monotherapy or in combination with methotrexate or other non-biologic DMARDs).
Polymyalgia rheumatica in patients who had an inadequate response to corticosteroids or cannot tolerate a corticosteroid taper.
Active polyarticular juvenile idiopathic arthritis (as monotherapy or in combination with non-biologic DMARDs).

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Active infection;
Hepatic impairment;
ANC <2000/mm³ (<500/mm³ while on therapy) or platelet count <150,000/mm³ (<50,000/mm³ while on therapy);
Concurrent use with biological DMARDs.

Use Cautiously in:

Chronic or recurrent infection;
History of serious or opportunistic infection;
Exposure to tuberculosis;
Lived in or traveled to areas of endemic tuberculosis or endemic mycoses;
Diverticulitis or concomitant use of NSAIDs or corticosteroids (↑ risk for GI perforation);
Severe renal impairment;
Geri: ↑risk of infections;
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.

Adv. Reactions/Side Effects ⬆ ⬇

GI: ↑liver enzymes, GI PERFORATION

Hemat: NEUTROPENIA, THROMBOCYTOPENIA

Local: injection site reactions

Metab: dyslipidemia

Misc: infection (including tuberculosis [TB], disseminated fungal infections, and infections with opportunistic pathogens), hypersensitivity reactions, MALIGNANCY

Interactions ⬆ ⬇

Drug-drug:

May alter the activity of CYP450 enzymes; the effects of the following drugs should be monitored: cyclosporine, theophylline, warfarin, hormonal contraceptives, atorvastatin, and lovastatin.
May ↓ antibody response to and ↑ risk of adverse reactions to live-virus vaccines; avoid concurrent use.

Availability ⬆ ⬇

Solution for SUBQ injection (prefilled syringes and pens): 150 mg/1.14 mL; 200 mg/1.14 mL

Route/Dosage ⬆ ⬇

Rheumatoid Arthritis

SC (Adults ): 200 mg every 2 wk.

Polymyalgia Rheumatica

SC (Adults ): 200 mg every 2 wk (in combination with a corticosteroid taper). May be used as monotherapy once corticosteroid taper is completed.

Polyarticular Juvenile Idiopathic Arthritis

SC (Adults and Children ≥63 kg): 200 mg every 2 wk.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Acts as an inhibitor of interleukin-6 (IL-6) receptors by binding to them. IL-6 is a mediator of various inflammatory processes.

Therapeutic effects:

Decreased pain and swelling with decreased rate of joint destruction in patients with rheumatoid arthritis and juvenile idiopathic arthritis.
Sustained remission in polymyalgia rheumatica.

Classifications ⬆ ⬇

Therapeutic Classification: antirheumatics, Immunosuppressant agents

Pharmacologic Classification: interleukin antagonists

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed via SUBQ injection.

Distribution: Well distributed to tissues.

Metabolism/Excretion: Metabolic pathway has not been defined. Elimination is predominantly through the linear, nonsaturable proteolytic pathway at high concentrations; at lower concentrations, elimination is predominately through nonlinear saturable target-mediated pathway.

Half-Life: 200 mg every 2 wk dose: up to 10 days; 150 mg every 2 wk dose: up to 8 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	2–4 days	28–43 days

Patient/Family Teaching ⬆ ⬇

Explain the purpose and side effects of sarilumab to patient. Do not stop receiving drug without consulting health care professional. If an appointment or dose is missed, contact health care professional as soon as possible to reschedule. Instruct patient and caregiver in correct technique for SUBQ injections and care and disposal of equipment. Rotate injection sites. Do not inject where skin is tender, damaged, bruised, or scarred. Advise patient to read the Medication Guide before starting and with each Rx refill in case of changes.
Caution patient to notify health care professional immediately if signs of infection (fever, sweating, chills, muscle aches, cough, shortness of breath, blood in phlegm, weight loss, warm, red or painful skin or sores, diarrhea or stomach pain that does not go away, burning on urination, urinary frequency, feeling tired).
Advise patient to immediately report and seek treatment for allergic reaction. Signs and symptoms of anaphylaxis might include swelling of face, lips, or tongue; hives; severe rash; shortness of breath; or chest pain.
Advise patient to avoid receiving live vaccines during therapy.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Instruct patient to notify health care professional of medication regimen prior to treatment or surgery.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Encourage women who become pregnant while taking sarilumab to participate in the pregnancy registry by going to https://mothertobaby.org/ongoing-study/kevzara/ or calling 1-877-311-8972.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0024- sanofi-aventis U.S. LLC
- 0024-5908- KEVZARA
  - 0024-5908-01- 2 SYRINGE in 1 PACKAGE (0024-5908-01) > 1.14 mL in 1 SYRINGE

0024- sanofi-aventis U.S. LLC
- 0024-5908- KEVZARA
  - 0024-5908-02- 2 SYRINGE in 1 PACKAGE (0024-5908-02) > 1.14 mL in 1 SYRINGE

0024- sanofi-aventis U.S. LLC
- 0024-5910- KEVZARA
  - 0024-5910-01- 2 SYRINGE in 1 PACKAGE (0024-5910-01) > 1.14 mL in 1 SYRINGE

0024- sanofi-aventis U.S. LLC
- 0024-5910- KEVZARA
  - 0024-5910-02- 2 SYRINGE in 1 PACKAGE (0024-5910-02) > 1.14 mL in 1 SYRINGE

0024- sanofi-aventis U.S. LLC
- 0024-5920- KEVZARA
  - 0024-5920-01- 2 SYRINGE in 1 PACKAGE (0024-5920-01) > 1.14 mL in 1 SYRINGE

0024- sanofi-aventis U.S. LLC
- 0024-5920- KEVZARA
  - 0024-5920-02- 2 SYRINGE in 1 PACKAGE (0024-5920-02) > 1.14 mL in 1 SYRINGE

0024- sanofi-aventis U.S. LLC
- 0024-5922- KEVZARA
  - 0024-5922-01- 2 SYRINGE in 1 PACKAGE (0024-5922-01) > 1.14 mL in 1 SYRINGE

0024- sanofi-aventis U.S. LLC
- 0024-5922- KEVZARA
  - 0024-5922-02- 2 SYRINGE in 1 PACKAGE (0024-5922-02) > 1.14 mL in 1 SYRINGE

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Indications ⬇