Arcalyst Side Effects

Generic Name: rilonacept

Note: This page contains information about the side effects of rilonacept. Some of the dosage forms included on this document may not apply to the brand name Arcalyst.

Not all side effects for Arcalyst may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to rilonacept: subcutaneous powder for solution

In addition to its needed effects, some unwanted effects may be caused by rilonacept (the active ingredient contained in Arcalyst). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking rilonacept:

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
  • chills
  • cough
  • difficulty in breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Incidence not known
  • Bloody or black, tarry stools
  • constipation
  • 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
  • tenderness
  • tightness of chest or wheezing
  • vomiting of blood or material that looks like coffee grounds

Some of the side effects that can occur with rilonacept may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
Less common
  • Stomach discomfort

For Healthcare Professionals

Applies to rilonacept: subcutaneous powder for injection

Local

In patients with Cryopyrin-Associated Periodic Syndromes (CAPS), the most common and consistently reported adverse event associated with rilonacept (the active ingredient contained in Arcalyst) 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.

Local side effects including injection-site reactions (48%) have been reported.

Immunologic

Immunologic side effects including infections (34%) have been reported.

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.

Respiratory

Respiratory side effects including upper respiratory tract infection (26%), sinusitis (9%), and cough (9%) have been reported.

Nervous system

Nervous system side effects including hypoesthesia (9%) have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea (4%) diarrhea (4%) and stomach discomfort (4%) have been reported.

Hematologic

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.

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.

Genitourinary

Genitourinary side effects including urinary tract infection (4%) have been reported.

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