Drug Interaction:
Metoprolol, carvediol, flecainide, vinblastine, thioridazine
TCADs Ketoconazole, itrakonazole, rifampicin, erthromycin,
Desipramine, Phenytoin St.Johns Wort
Indication:
FDA approved label August 1, 2011
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Sensipar safely and effectively. See full prescribing information for Sensipar. Sensipar® (cinacalcet) Tablets
Initial US Approval: 2004
Hypercalcemia in patients with parathyroid carcinoma
Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
Cinacalet Hcl tablet 14-01-2009
30/60/90mg
For the treatment of secondary hyper-parathyroidm in patients with
chronic kidney diseases (CKD) on dialysis for hypercalcemia in
patients with parathyoid carcinoma
Adverse Reaction:
Nausea, anorexia, dizziness, parathesthesia, rash, myalgia, chest pain
Asthnenia, hypocalcemia,
Reduced testosterone levels
Seizures
Hypotension
Worsensing cardiac failure
Angioedema
Contra-Indications:
Hypercalcemia Lactation
Special precautions
Moderate to severe hepatic impairment Impaired cardiac function
Epilepsy In hyperparathyroidism monitor parathyroid levels 1- 4 weeks after initiation or dose adjustment and regulary during maintenance
Suspend therapy if serum calcium < 7.5mg/dL Changes in smoking habits
Pregnancy
History of seizures
Dosages/ Overdosage Etc:
Indication-
Hypercalcemia in patients with parathyroid carcinoma
Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis Parathyroid carcinoma and primary hyperparathyroidism
Dosage-
initially 30mg twice daily
Titrate every 2- 4 weeks to 60mg twice daily, then 90mg twice daily then 90mg three or four times daily as necessary to reduce serum calcium to below ULN
Maximum - 90mg four times daily
secondary hyperparathyroidism - Initially 30mg once daily
Titrate evey 2-4 weeks acording to target parathyoid level
Maximum 180mg once daily
Patients below 18 years - not recommended
Patient Information:
PATIENT COUNSELING INFORMATION
• Take with food: Patients should be advised to take Sensipar with food or shortly after a meal. Tablets should be taken whole and should not be divided.
• Laboratory monitoring: Patients should be informed of the importance of regular blood tests, in order to monitor the safety and efficacy of Sensipar therapy.
• Side-Effects of Treatment: Patients should be advised to report nausea, vomiting, and potential symptoms of hypocalcemia, including tingling/numbness of the skin, muscle pain, and muscle cramping.
• Seizures: Patients should be queried if they are taking medication to prevent seizures or have had seizures in the past and be advised to report any seizure episodes while on Sensipar therapy.
Sensipar® (cinacalcet) Tablets Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 This product, or its use, may be covered by one or more US Patents including US Patent Nos. 6,313,146; 6,211,244; 6,031,003; 6,011,068, and 7,829,595
Interaction with Food:
Take with food or shortly after food.
Swallow whole. Do no divide
Pregnancy and lactation:
Contraindicated during pregnancy and lactation
Manufacturer Details