Satralizumab

Satralizumab is a prescription medication used for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 antibody (AQP4) positive.

• Satralizumab is available under the following different brand names: Enspryng, Satralizumab-mwge

Common side effects of Satralizumab include:

• runny or stuffy nose
• headache
• upper respiratory tract infection
• gastritis
• rash
• joint pain
• extremity pain
• fatigue
• nausea

Serious side effects of Satralizumab include:

• hives
• light-headedness
• stomach pain
• vomiting
• difficult breathing
• swelling of the face, lips, tongue, or throat
• chest pain
• diarrhea
• stomach cramps
• loss of appetite
• weight loss
• increased urination, burning sensation during urinating
• skin sores, redness, swelling, or tenderness

Rare side effects of Satralizumab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because 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

Solution for SC injection

• 120 mg/mL single-dose prefilled syringe

Neuromyelitis optica spectrum disorder

Adult dosage

• Loading: 120 mg SC at weeks 0, 2, and 4
• Maintenance: 120 mg SC every 4 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, healthcare provider, or pharmacist first.

• Satralizumab has severe interactions with no other drugs.
• Satralizumab has serious interactions with at least 21 other drugs.
• Satralizumab has moderate interactions with at least 41 other drugs.
• Satralizumab 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 the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity
• Active hepatitis B infection
• Active or untreated latent tuberculosis (TB)

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Hypersensitivity reactions, including rash, urticaria, and fatal anaphylaxis, have occurred with other interleukin 6 (IL-6) antagonists
• Increased risk for infections, including serious and potentially fatal ones, were observed with IL-6 antagonists, including satralizumab; risk of hepatitis B virus reactivation or TB infection

Mild and moderate liver enzyme elevations observed; monitor before and during treatment

• Regularly monitor neutrophil count during treatment
• Drug interaction overview
• Vaccines
  • Vaccination with live-attenuated or live vaccines is not recommended during treatment
  • Administer all vaccines according to immunization guidelines at least 4 weeks before initiating Satralizumab when possible (or at least 2 weeks before initiation of nonlive vaccines)
• CYP450 substrates
  • Clinical significance unknown
  • IL-6 signaling suppression is expected to have a minor impact on the exposure of concomitant medications metabolized by CYP450 enzymes

Pregnancy and Lactation

• Data are not available regarding the developmental risk associated with the drug’s use in pregnant women
• Clinical considerations
  • Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester
  • Consider the risks and benefits before administering live or live-attenuated vaccines to infants exposed to Satralizumab in utero
• Pregnancy exposure registry
  • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to this drug during pregnancy
  • Healthcare providers are encouraged to register patients, and pregnant women are encouraged to register themselves by calling 1-833-277-9338
• Lactation
  • No information available on the drug’s excretion in human milk or its effects on breastfed infants or milk production
  • Human IgG excreted in human milk; potential for absorption in an infant is unknown