Endo Begins Shipment of Generic MIACALCIN® (calcitonin salmon) Injection
"We are very pleased to offer this generic, therapeutically equivalent calcitonin salmon injectable," said
According to IQVIA data,
MIACALCIN® is a registered trademark of Novartis AG, licensed to the Viatris Companies.
IMPORTANT SAFETY INFORMATION
Calcitonin salmon injection is indicated for the treatment of symptomatic Paget's disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. There is no evidence that the prophylactic use of calcitonin salmon is beneficial in asymptomatic patients. Calcitonin salmon injection should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).
Calcitonin salmon injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents.
Calcitonin salmon injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. The evidence of efficacy for calcitonin salmon injection is based on increases in total body calcium observed in clinical trials. Fracture reduction efficacy has not been demonstrated. Calcitonin salmon injection should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).
Important Limitations of Use
Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis.
IMPORTANT SAFETY INFORMATION
Hypersensitivity to calcitonin salmon or any of the excipients. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat.
WARNINGS AND PRECAUTIONS
Serious hypersensitivity reactions have been reported in patients receiving calcitonin salmon injection, e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis. Appropriate medical support and monitoring measures should be readily available when calcitonin salmon injection is administered. If anaphylaxis or other severe hypersensitivity/allergic reactions occur, initiate appropriate treatment.
For patients with suspected hypersensitivity to calcitonin salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of calcitonin salmon injection. Healthcare providers may wish to refer patients who require skin testing to an allergist.
Hypocalcemia associated with tetany (i.e., muscle cramps, twitching) and seizure activity has been reported with calcitonin salmon injection therapy. Hypocalcemia must be corrected before initiating therapy. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. In patients at risk for hypocalcemia, provisions for parenteral calcium administration should be available during the first several administrations of calcitonin salmon and serum calcium and symptoms of hypocalcemia should be monitored. Use of calcitonin salmon injection for the treatment of postmenopausal osteoporosis is recommended in conjunction with an adequate intake of calcium and vitamin D.
In a meta-analysis of 21 randomized, controlled clinical trials with calcitonin salmon (nasal spray or investigational oral formulations), the overall incidence of malignancies reported was higher among calcitonin salmon-treated patients (4.1%) compared with placebo-treated patients (2.9%). This suggests an increased risk of malignancies in calcitonin salmon-treated patients compared to placebo-treated patients. It is not possible to exclude an increased risk when calcitonin salmon is administered long-term subcutaneously, intramuscularly, or intravenously. The benefits for the individual patient should be carefully considered against possible risks.
Circulating antibodies to calcitonin salmon have been reported with calcitonin salmon injection. The possibility of antibody formation should be considered in any patient with an initial response to calcitonin salmon injection who later stops responding to treatment.
Urine Sediment Abnormalities
Coarse granular casts and casts containing renal tubular epithelial cells were reported in young adult volunteers at bed rest who were given injectable calcitonin salmon to study the effect of immobilization on osteoporosis. There was no other evidence of renal abnormality and the urine sediment normalized after calcitonin salmon was stopped. Periodic examinations of urine sediment should be considered.
The safety of calcitonin salmon injection was assessed in open-label trials several months to two years in duration. The most common adverse reactions are discussed below.
Nausea: Nausea with or without vomiting has been noted in about 10% of patients treated with calcitonin salmon. It is most evident when treatment is first initiated and tends to decrease or disappear with continued administration.
Dermatologic Reactions: Local inflammatory reactions at the site of subcutaneous or intramuscular injection have been reported in about 10% of patients.
Other Adverse Reactions: Nocturia, feverish sensation, pain in the eyes, poor appetite, abdominal pain, pedal edema, and salty taste have been reported in patients treated with calcitonin salmon injection.
No formal drug interaction studies have been performed with calcitonin salmon injection.
Concomitant use of calcitonin salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may require adjustment.
The pharmacologic actions of calcitonin salmon injection suggest that hypocalcemic tetany could occur in overdose. Therefore, provisions for parenteral administration of calcium should be available for the treatment of overdose.
A dose of calcitonin salmon 1000 International Units (IU) subcutaneously may produce nausea and vomiting. Doses of 32 IU per kg per day for 1 to 2 days demonstrate no other adverse effects. Data on chronic high-dose administration are insufficient to assess toxicity.
Click for Full Prescribing Information for calcitonin salmon injection.
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About Par Pharmaceutical
Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical and branded injectable products that help improve patient quality of life. Par, among the top leaders in the
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