Rilonacept

Rilonacept is a prescription medication used for the treatment of is an interleukin inhibitor used to treat some of the symptoms of rare genetic conditions such as of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS), Maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA), Recurrent Pericarditis (RP), and Muckle-Wells Syndrome (MWS). .

• Rilonacept is available under the following different brand names: Arcalyst

Common side effects of Rilonacept include:

• cold symptoms (sneezing, runny or stuffy nose, sore throat, cough)
• nausea
• stomach pain
• diarrhea
• numbness or tingly feeling
• injection site reactions (pain, swelling, redness, itching, bleeding, warmth, blistering, or other irritation)

Serious side effects of Rilonacept include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• dizziness
• fever
• chills
• sore throat
• open sores on the body
• cough with mucus
• shortness of breath
• headache
• neck stiffness
• increased sensitivity to light
• confusion
• chest discomfort
• wheezing
• dry cough
• rapid weight loss
• bloody, black, or tarry stools
• coughing up blood
• vomit that looks like coffee grounds
• pain or burning while urinating
• ear pain or full feeling
• trouble hearing
• drainage from the ear
• purple spots on the skin
• seizure (convulsions)
• fussiness in a child

Rare side effects of Rilonacept 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, loss of coordination, feeling 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

Injection, lyophilized powder for reconstitution

• 220 mg/vial

Cryopyrin Associated Periodic Syndromes

Adult dosage

• Loading dose: 320 mg SC x 1 dose
• Maintenance: 160 mg SC every week

Pediatric dosage

• Aged below 12 years: Safety and efficacy not established
• 12-17 years
  • Loading dose: 4.4 mg/kg SC; not to exceed 320 mg total dose  
  • Maintenance: 2.2 mg/kg SC; not to exceed 160 mg/dose and 2 mL/injection
• Aged above 18 years
  • Loading dose: 320 mg SC once
  • Maintenance: 160 mg SC every week

Deficiency of Interleukin-1 Receptor Antagonist

Adult dosage

• 4.4 mg/kg (not to exceed 320 mg) SC once weekly

Pediatric dosage

• Aged above 10 kg
  • 4.4 mg/kg not to exceed 320 mg) SC once weekly

Recurrent Pericarditis

Adult dosage

• Loading dose: 320 mg SC x 1 dose
• Maintenance: 160 mg SC every week

Pediatric dosage

• Aged below 12 years: Safety and efficacy not established
• Aged between 12-17 years
  • Loading dose: 4.4 mg/kg SC; not to exceed 320 mg total dose  
  • Maintenance: 2.2 mg/kg SC; not to exceed 160 mg/dose and 2 mL/injection
• Aged above 18 years
  • Loading dose: 320 mg SC x 1 dose
  • Maintenance: 160 mg SC every week

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.

• Rilonacept has severe interactions with no other drugs.
• Rilonacept has serious interactions with at least 71 other drugs.
• Rilonacept has moderate interactions with at least 22 other drugs.
• Rilonacept 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 healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Hypersensitivity reactions reported but rare; if hypersensitivity reaction occurs, discontinue treatment and initiate appropriate therapy
• Monitor for changes in lipid profiles and treat appropriately
• Immunosuppressants increase the risk of malignancies
• Increases in non-fasting lipid profile parameters reported; monitor patients’ lipid profiles and consider lipid-lowering therapies if needed, based on cardiovascular risk factors and current guidelines
• Infections
  • Interleukin-1 blockade may interfere with immune response to infections
  • Serious, life-threatening infections reported
  • Discontinue treatment with if serious infection develops
  • Do not initiate in patients with active or chronic infections
• Drug interaction overview
  • Live vaccines
  • Do not give live vaccines concurrently with rilonacept
  • Before initiation, patients should receive all recommended vaccinations
  • TNF-blocking agent and IL-1 blocking agent
• Not recommended
  • Coadministration of drug that blocks IL-1 with a TNF-blocking agent associated with increased risk of serious infections and neutropenia
  • CYP450 substrates
  • Monitor therapeutic effect or drug concentration of CYP450 substrates with narrow therapeutic index; adjust dose accordingly
  • Increased levels of cytokines (eg, IL-1) suppress formation of CYP450 enzymes during chronic inflammation
  • Rilonacept may normalize the formation of these cytokines
  • May affect CYP450 substrates with narrow therapeutic indexes

Pregnancy and Lactation

• Data are insufficient on use in pregnant females to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Disease-associated maternal and/or embryofetal risk
• Published data suggest that increased maternal levels of interleukin (IL)-1beta, which induces inflammation that occurs in CAPS, may be associated with preterm birth
• Lactation
  • There is no information on presence in either human or animal milk, effects on breastfed infants, or effects on milk production