almost about [1%:<1,500/mm 3 ) was reported; monitor blood counts as indicated. Hypersensitivity: Hypersensitivity reactions (excluding anaphylactic reactions) have been reported with use; symptoms may be similar to those that are disease related. Infections: Caution should be exercised when considering use in patients with a history of new/recurrent infections, with conditions that predispose them to infections, or with latent or localized infections. Patients who develop a new infection while undergoing treatment should be monitored closely. If a patient develops a serious infection, therapy should be discontinued. Therapy should not be initiated in patients with active or chronic infections. Macrophage activation syndrome (MAS): MAS may develop in patients with SJIA and should be treated aggressively. Infection or worsening SJIA may be triggers for MAS. Malignancy: Use may impair defenses against malignancies; impact on the development and course of malignancies is not fully defined. Tuberculosis: Avoid use in patients with active tuberculosis (TB). Patients should be evaluated for latent tuberculosis infection with a tuberculin skin test prior to starting therapy. Treat latent TB infections prior to initiating canakinumab therapy. During and following treatment, monitor for signs/symptoms of active TB. Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Dosage form specific issues: Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer s labeling. Other warnings/precautions: Immunizations: All patients should be brought up to date with all immunizations including pneumococcal and influenza vaccines before initiating therapy. Live vaccines should not be given concurrently; no data available on either the efficacy or on the risks concerning secondary transmission of infection by live vaccines in patients receiving therapy. Administration of inactivated (killed) vaccines while on therapy may not be effective. Monitoring Parameters CBC with differential, C-reactive protein (CRP), serum amyloid A protein A (SAA); signs of infection; latent TB screening (prior to initiating therapy). Eye examinations for patients with CAPS (Caorsi 2013) and symptoms of disease for patients with CAPS or SJIA (Caorsi 2013; Lachmann 2009; Ruperto 2012) were also monitored in clinical trials. Pregnancy Considerations Adverse events have been observed in animal reproduction studies. Canakinumab is a recombinant IgG monoclonal antibody; IgG is known to cross the placenta in a linear fashion as pregnancy progresses; potential fetal exposure is likely to be greater during the second and third trimesters. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience signs of common cold, headache, abdominal pain, diarrhea, muscle pain, flu-like symptoms, rhinorrhea, pharyngitis, or weight gain. Have patient report immediately to prescriber signs of infection, persistent cough, weight loss, dizziness, passing out, severe injection site irritation, difficulty swallowing, severe nausea, severe vomiting, abnormal heartbeat, or signs of macrophage activation syndrome (worsening of arthritis, fever for more than 3 days, persistent cough, redness in one part of your body, or a warm feeling or swelling of your skin) (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about canakinumab Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En EspaƱol 0 Reviews Add your own review/rating Drug class: interleukin inhibitors Consumer resources Canakinumab Canakinumab Subcutaneous (Advanced Reading) Professional resources Canakinumab (AHFS Monograph) Other brands: Ilaris Related treatment guides Cryopyrin-Associated Periodic Syndromes Familial Cold Autoinflammatory Syndrome Familial Mediterranean Fever Hyperimmunoglobulin D Syndrome ... +3 more> 1,500/mm>] Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Canakinumab Rating No Reviews - Be the first! 10 /10 No Reviews - Be the first! 10 Rate it! 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