Sarilumab

Sarilumab is a prescription medication used to treat the symptoms of moderately to severely active rheumatoid arthritis. 

• Sarilumab is available under the following different brand names: Kevzara

Common side effects of Sarilumab include:

• low white blood cell count (neutropenia),
• increased ALT,
• injection site redness,
• upper respiratory infections,
• nasal congestion,
• runny nose,
• sore throat,
• urinary tract infections, and
• low platelet counts (thrombocytopenia).

Serious side effects of Sarilumab include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• light-headedness,
• chest pain,
• fever,
• chills,
• sweating,
• body aches,
• cough with bloody mucus,
• shortness of breath,
• diarrhea,
• stomach pain,
• weight loss,
• sores on your skin,
• pain or burning while urinating,
• tiredness,
• ongoing stomach pain, and
• change in bowel habits

Rare side effects of Sarilumab include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution (prefilled syringe)

• 150mg/1.14mL
• 200mg/1.14mL

Injectable solution (prefilled pen)

• 150mg/1.14mL
• 200mg/1.14mL

Rheumatoid Arthritis

Adult dosage

• 200 mg subcutaneous every 2 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Sarilumab has severe interactions with no other drugs
• Sarilumab has serious interactions with the following drugs:
  • adenovirus types 4 and 7 live, oral
  • anthrax vaccine adsorbed
  • axicabtagene ciloleucel
  • BCG vaccine live
  • brexucabtagene autoleucel
  • cholera vaccine
  • ciltacabtagene autoleucel
  • idecabtagene vicleucel
  • lisocabtagene maraleucel
  • measles (rubeola) vaccine
  • measles, mumps, rubella, and varicella vaccine, live
  • rotavirus oral vaccine, live
  • rubella vaccine
  • smallpox (vaccinia) vaccine, live
  • tisagenlecleucel
  • typhoid vaccine live
  • upadacitinib
  • varicella virus vaccine live
  • yellow fever vaccine
  • zoster vaccine live
• Sarilumab has moderate interactions with at least 23 other drugs.
• Sarilumab has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Documented hypersensitivity to the drug or inactive ingredients 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Sarilumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sarilumab?”

Cautions

• Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported (see Black Box Warnings)
• GI perforations are reported in clinical studies, primarily as complications of diverticulitis; GI perforation risk may be increased with concurrent diverticulitis or concomitant use of NSAIDs or corticosteroids
• Immunosuppression may result in an increased risk of malignancies
• Hypersensitivity reactions reported
• Not recommended with active hepatic disease or hepatic impairment

Laboratory abnormalities

• Neutropenia, thrombocytopenia, elevated liver enzymes, and lipid abnormalities were reported (see Dosage Modifications)
• Assess platelet count before initiation of therapy and monitor platelets 4 to 8 weeks after the start of therapy and every 3 months thereafter
• Assess ALT/AST levels before initiation of therapy and monitor ALT and AST levels 4 to 8 weeks after the start of therapy and every 3 months thereafter; when clinically indicated, consider other liver function tests such as bilirubin
• Assess lipid parameters approximately 4-8 weeks following initiation of therapy, then at approximately 6-month intervals; manage patients according to clinical guidelines for the management of hyperlipidemia

Drug interaction overview

• Live virus vaccines
  • Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections
  • The interval between live vaccinations and initiation of sarilumab therapy should be by current vaccination guidelines regarding immunosuppressive agents
• CYP450 substrates
  • The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (.g, IL-1, IL-6, IL-10, TNF-alpha, IFN) during chronic inflammation
  • Elevated IL-6 concentration may down-regulate CYP activity, such as in patients with RA, and, hence, increase drug levels compared with subjects without RA
  • Blockade of IL-6 signaling by IL-6 antagonists (.g, sarilumab) might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to decreased drug concentrations
  • Caution when initiating or discontinuing sarilumab if Co-administered with CYP450 substrates, especially those with a narrow therapeutic index
• Biological DMARDs
  • Avoid coadministering with biological DMARDs (.g, TNF antagonists, IL-1R antagonists, antiCD20 monoclonal antibodies, JAK inhibitors, selective costimulation modulators) because of increased risk for immunosuppression and infection
  • Coadministration with biological DMARDs has not been studied

Pregnancy & Lactation

• Limited human data in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage
• Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester
• Risks and benefits should be considered before administering live or live-attenuated vaccines to infants exposed in utero
• From the animal data, and consistent with the mechanism of action, levels of IgG, in response to antigen challenge, may be reduced in the fetus/infant of treated mothers

Pregnancy registry

• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to sarilumab during pregnancy
• Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972

Lactation

• Unknown if distributed in human breast milk
• Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition