Therapeutic Indications

Canacinumab is indicated for:

Familial Mediterranean fever (FMF)

Irrespective of gender only Children (1 year - 12 years old) , Adolescents (12 years - 18 years old) Adults (18 years old or older)

Canakinumab is indicated for the treatment of Familial Mediterranean Fever (FMF). Canakinumab should be given in combination with colchicine, if appropriate.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 2-4 mg/kg once every 4 weeks

Hyperimmunoglobulin D syndrome (HIDS), mevalonate kinase deficiency (MKD)

Irrespective of gender only Children (1 year - 12 years old) , Adolescents (12 years - 18 years old) Adults (18 years old or older)

Canakinumab is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD).

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 2-4 mg/kg once every 4 weeks

Tumour necrosis factor receptor associated periodic syndrome (TRAPS)

Irrespective of gender only Children (1 year - 12 years old) , Adolescents (12 years - 18 years old) Adults (18 years old or older)

Canakinumab is indicated for the treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS).

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 2-4 mg/kg once every 4 weeks

Still's disease

Irrespective of gender only Children (1 year - 12 years old) , Adolescents (12 years - 18 years old) Adults (18 years old or older)

Canakinumab is indicated for the treatment of active Still’s disease including adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Canakinumab can be given as monotherapy or in combination with methotrexate.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 4 mg/kg once every 4 weeks

Cryopyrin associated periodic syndromes (CAPS)

Irrespective of gender only Children (1 year - 12 years old) , Adolescents (12 years - 18 years old) Adults (18 years old or older)

Canakinumab is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including:

  • Muckle-Wells syndrome (MWS),
  • Neonatal-onset multisystem inflammatory disease (NOMID)/chronic infantile neurological, cutaneous, articular syndrome (CINCA),
  • Severe forms of familial cold autoinflammatory syndrome (FCAS)/familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 2-4 mg/kg once every 8 weeks

Gouty arthritis

Irrespective of gender only Adolescents (12 years - 18 years old) Adults (18 years old or older)

Canakinumab is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 150 mg once

Contraindications

Active ingredient Canacinumab is contraindicated in the following cases:

Infections

No gender/age discrimination

Canakinumab is associated with an increased incidence of serious infections. Therefore patients should be monitored carefully for signs and symptoms of infections during and after treatment with canakinumab. Physicians should exercise caution when administering canakinumab to patients with infections, a history of recurring infections, or underlying conditions which may predispose them to infections.

Treatment of CAPS, TRAPS, HIDS/MKD, FMF and Still’s disease (SJIA and AOSD)

Canakinumab should not be initiated or continued in patients during an active infection requiring medical intervention.

Treatment of gouty arthritis

Canakinumab should not be administered during an active infection. Concomitant use of canakinumab with tumour necrosis factor (TNF) inhibitors is not recommended because this may increase the risk of serious infections.

Isolated cases of unusual or opportunistic infections (including aspergillosis, atypical mycobacterial infections, herpes zoster) have been reported during canakinumab treatment. The causal relationship of canakinumab to these events cannot be excluded.

Tuberculosis screening

In approximately 12% of CAPS patients tested with a PPD (purified protein derivative) skin test in clinical trials, follow-up testing yielded a positive test result while treated with canakinumab without clinical evidence of a latent or active tuberculosis infection.

It is unknown whether the use of interleukin-1 (IL-1) inhibitors such as canakinumab increases the risk of reactivation of tuberculosis. Before initiation of therapy, all patients must be evaluated for both active and latent tuberculosis infection. Particularly in adult patients, this evaluation should include a detailed medical history. Appropriate screening tests (e.g. tuberculin skin test, interferon gamma release assay or chest X-ray) should be performed in all patients (local recommendations may apply). Patients must be monitored closely for signs and symptoms of tuberculosis during and after treatment with canakinumab. All patients should be instructed to seek medical advice if signs or symptoms suggestive of tuberculosis (e.g. persistent cough, weight loss, subfebrile temperature) appear during canakinumab therapy. In the event of conversion from a negative to a positive PPD test, especially in high-risk patients, alternative means of screening for a tuberculosis infection should be considered.