Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Hypersensitivity Reactions, including anaphylaxis [see Warnings and Precautions ( 5.1 )] Hypocalcemia [see Warnings and Precautions ( 5.2 )] Malignancy [see Warnings and Precautions ( 5.3 )] Most common adverse reactions are nausea with or without vomiting (10%), injection site inflammation (10%), and flushing of the face or hands (2% to 5%) ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc.
at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
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.
Flushing of face or hands occurred in about 2% to 5% of patients.
Skin rashes and pruritus of the ear lobes have also been reported.
5 WARNINGS AND PRECAUTIONS Serious hypersensitivity reactions, including reports of fatal anaphylaxis have been reported.
Consider skin testing prior to treatment in patients with suspected hypersensitivity to calcitonin salmon ( 5.1 ) Hypocalcemia has been reported.
Ensure adequate intake of calcium and vitamin D ( 5.2 ) Malignancy: A meta-analysis of 21 clinical trials suggests an increased risk of overall malignancies in calcitonin salmon-treated patients ( 5.3 , 6.1 ) Circulating antibodies to calcitonin salmon may develop, and may cause loss of response to treatment ( 5.4 ) 5.1 Hypersensitivity Reactions 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 [see Contraindications ( 4 )].
Like all medications, Calcitonin Salmon can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: