Rilonacept Side Effects
Commonly reported side effects of rilonacept include: upper respiratory tract infection and injection site reaction. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to rilonacept: subcutaneous powder for solution
As well as its needed effects, rilonacept may cause unwanted side effects that require medical attention.
Major Side Effects
If any of the following side effects occur while taking rilonacept, check with your doctor immediately:More common:
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site
- body aches or pain
- difficulty in breathing
- ear congestion
- loss of voice
- nasal congestion
- runny nose
- sore throat
- unusual tiredness or weakness
- Bloody or black, tarry stools
- cough producing mucus
- lower back or side pain
- pain or tenderness around eyes and cheekbones
- painful or difficult urination
- severe stomach pain
- shortness of breath or troubled breathing
- tightness of chest or wheezing
- vomiting of blood or material that looks like coffee grounds
Minor Side Effects
Some rilonacept side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:More common:
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- Stomach discomfort
For Healthcare Professionals
Applies to rilonacept: subcutaneous powder for injection
In patients with Cryopyrin-Associated Periodic Syndromes (CAPS), the most common and consistently reported adverse event associated with rilonacept was injection-site reaction (ISR). The ISRs included erythema, swelling, pruritis, mass, bruising, inflammation, pain, edema, dermatitis, discomfort, urticaria, vesicles, warmth, and hemorrhage. Most injection-site reactions lasted for one to two days. No ISRs were assessed as severe, and no patient discontinued study participation due to an ISR.[Ref]
Local side effects including injection-site reactions (48%) have been reported.[Ref]
One subject receiving rilonacept for an unapproved indication developed an infection in his olecranon bursa with Mycobacterium intracellulare. The patient was on chronic glucocorticoid treatment. The infection occurred after an intraarticular glucocorticoid injection into the bursa with subsequent local exposure to a suspected source of mycobacteria. The patient recovered after the administration of the appropriate antimicrobial therapy.
A patient treated for another unapproved indication developed bronchitis/sinusitis, which resulted in hospitalization.
One patient died in an open-label study of CAPS from Streptococcus pneumoniae meningitis.[Ref]
Immunologic side effects including infections (34%) have been reported.[Ref]
Respiratory side effects including upper respiratory tract infection (26%), sinusitis (9%), and cough (9%) have been reported.[Ref]
Nervous system side effects including hypoesthesia (9%) have been reported.[Ref]
Gastrointestinal side effects including nausea (4%) diarrhea (4%) and stomach discomfort (4%) have been reported.[Ref]
Hematologic side effects have been reported including one case of transient neutropenia (ANC less than 1 x 109/L) after receiving a large dose (2000 mg intravenously) of rilonacept. Patients with CAPS treated with rilonacept experienced increases in their mean total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides. The mean increases from baseline for total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides were 19 mg/dL, 2 mg/dL, 10 mg/dL, and 57 mg/dL respectively after 6 weeks of open-label therapy.[Ref]
The patient did not experience any infection associated with the neutropenia.
Physicians should monitor the lipid profiles of their patients (for example after 2 to 3 months) and consider lipid-lowering therapies as needed based upon cardiovascular risk factors and current guidelines.[Ref]
Genitourinary side effects including urinary tract infection (4%) have been reported.[Ref]
1. "Product Information. Arcalyst (rilonacept)." Regeneron Pharmaceuticals Inc, Tarrytown, NY.
It is possible that some side effects of rilonacept may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
More about rilonacept
- Other brands: Arcalyst
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