Generic drug: rilonacept
Brand name: Arcalyst
What is Arcalyst (rilonacept), and how does it work?
Arcalyst is a prescription medicine called an interleukin-1 (IL-1) blocker.
- Arcalyst is used to treat adults and children 12 years of age and older with Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle Wells Syndrome (MWS).
- Arcalyst is used to maintain control of symptoms of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and children weighing at least 22 pounds (10 kg).
It is not known if Arcalyst is safe and effective in children with CAPS under 12 years of age.
It is not known if Arcalyst is safe and effective in children with DIRA weighing less than 22 pounds (10 kg).
What are the side effects of Arcalyst?
Arcalyst can cause serious side effects, including:
- Changes in your blood cholesterol and triglycerides (lipids). Your or your child’s healthcare provider will do blood tests to check for this.
- Allergic Reaction. Stop taking or giving Arcalyst and call the healthcare provider or get emergency care right away if you or your child get any of the following symptoms of an allergic reaction while taking
Arcalyst:
In people with CAPS, the most common side effects of Arcalyst include:
- Injection-site reactions including: pain, redness, swelling, itching, bruising, lumps, inflammation, skin rash, blisters, warmth, and bleeding at the injection site.
- Upper respiratory infection.
In people with DIRA, the most common side effects of Arcalyst include:
- Upper respiratory infection
- Rash
- Ear infection
- Sore throat
- Runny nose
These are not all the possible side effects of Arcalyst. Tell your healthcare provider if you have any side effect that bothers you or does not go away. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Arcalyst?
General Dosing Information
Arcalyst is for subcutaneous use only.
Cryopyrin-Associated Periodic Syndromes, Familial Cold Auto-Inflammatory Syndrome, Muckle-Wells Syndrome And Recurrent Pericarditis
Adults
- Initiate treatment with a loading dose of 320 mg delivered as two, 2-mL, subcutaneous injections of 160 mg each, administered on the same day at two different injection sites.
- Continue dosing with a once-weekly injection of 160 mg administered as a single, 2-mL, subcutaneous injection.
Pediatric Patients 12 Years To 17 Years
- Initiate treatment with a loading dose of 4.4 mg/kg, up to a maximum dose of 320 mg, administered as one or two subcutaneous injections, not to exceed single-injection volume of 2 mL per injection site.
- If the initial dose is given as two injections, administer on the same day at two different sites.
- Continue dosing with a once-weekly injection of 2.2 mg/kg, up to a maximum of 160 mg, administered as a single subcutaneous injection, up to 2 mL.
- If a once weekly dose is missed, instruct the patient to administer the injection within 7 days from the missed dose and then resume the patient’s original schedule.
- If the missed dose is not administered within 7 days, instruct the patient to administer the dose, starting a new schedule based on this date.
Deficiency Of IL-1 Receptor Antagonist
Adults
- The recommended dose of Arcalyst is 320 mg, once weekly, administered as two subcutaneous injections on the same day at two different sites with a maximum single-injection volume of 2 mL.
Arcalyst should not be given more often than once weekly.
Pediatric Patients Weighing 10 Kg Or More
- The recommended dose of Arcalyst is 4.4 mg/kg (up to a maximum of 320 mg), once weekly, administered as one or two subcutaneous injections with a maximum single-injection volume of 2 mL. If the dose is given as two injections, administer both on the same day, each one at a different site.
- When switching from another IL-1 blocker, discontinue the IL-1 blocker
and begin Arcalyst treatment at the time of the next dose.
What drugs interact with Arcalyst?
TNF-Blocking Agent And IL-1 Blocking Agent
- Specific drug interaction studies have not been conducted with Arcalyst.
- Concomitant administration of another drug that blocks IL-1 with a
TNF-blocking agent in another patient population has been associated with an
increased risk of serious infections and an increased risk of neutropenia.
The concomitant administration of Arcalyst with TNF-blocking agents may also
result in similar toxicities and is not recommended. - The concomitant administration of Arcalyst with other drugs that block IL-1 has not been studied.
- Based upon the potential for pharmacologic interactions between rilonacept and a recombinant IL-1ra, concomitant administration of
Arcalyst and other agents that block IL-1 or its receptors is not recommended.
Cytochrome P450 Substrates
- The formation of CYP450 enzymes is suppressed by increased levels of cytokines (e.g., IL-1) during chronic inflammation.
- Thus it is expected that for a molecule that binds to IL-1, such as rilonacept, the formation of CYP450 enzymes could be normalized.
- This is clinically relevant for CYP450 substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g., warfarin).
- Upon initiation of Arcalyst, in patients being treated with these types of medicinal products, therapeutic monitoring of the effect or drug concentration should be performed, and the individual dose of the medicinal product may need to be adjusted as needed.
Is Arcalyst safe to use while pregnant or breastfeeding?
- Rare pregnancy outcomes reported postmarketing and from clinical trials, with very limited use of
Arcalyst in pregnant women, are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. - There may be risks to the mother and fetus associated with Cryopyrin Associated Periodic Syndromes (CAPS).
- There is no information on the presence of rilonacept in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.
- The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for
Arcalyst and any potential adverse effects on the breastfed child from
Arcalyst or from the underlying maternal condition.