Summary

Commonly reported side effects of rilonacept include: upper respiratory tract infection and injection site reaction. Continue reading for a comprehensive list of adverse effects.

Applies to rilonacept: subcutaneous powder for solution.

Serious side effects of Rilonacept

Along with its needed effects, rilonacept may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while 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
• runny or stuffy nose
• sneezing
• sore throat
• unusual tiredness or weakness

Less common

• Bladder pain
• bloody or cloudy urine
• diarrhea
• difficult, burning, or painful urination
• frequent urge to urinate
• lower back or side pain
• stomach discomfort or pain

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
• tenderness
• tightness of chest
• trouble breathing
• vomiting of blood or material that looks like coffee grounds

Other side effects of Rilonacept

Some side effects of rilonacept may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

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 was injection-site reaction (ISR). The ISRs included erythema, swelling, pruritus, 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]

Very common (10% or more): Injection site reactions (e.g., erythema, swelling, pruritus, mass, bruising, inflammation, pain, edema, dermatitis, discomfort, urticaria, vesicles, warmth, hemorrhage) (48%)^[Ref]

Immunologic

Very common (10% or more): Infection (34%)^[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]

Respiratory

Very common (10% or more): Upper respiratory tract infection (26%)

Common (1% to 10%): Sinusitis, cough^[Ref]

Nervous system

Common (1% to 10%): Hypoesthesia^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, stomach disorder^[Ref]

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.^[Ref]

Frequency not reported: Neutropenia^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection^[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity^[Ref]

Metabolic

Frequency not reported: Increased mean total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides (in patients with CAPS)^[Ref]

General

The most commonly reported adverse reaction is injection-site reaction (ISR). The next most commonly reported adverse reaction is upper respiratory infection.^[Ref]