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Calcitonin salmon
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- Active ingredient
- Calcitonin Salmon 200 [USP'U]/1 mL
- Other brand names
- Calcitonin Salmon (by Amneal Pharmaceuticals Llc)
- Calcitonin Salmon (by Apotex Corp.)
- Calcitonin Salmon (by Dr. Reddy's Laboratories, Inc.)
- Calcitonin Salmon (by Endo Usa, Inc.)
- Calcitonin Salmon (by Fresenius Kabi Usa, Llc)
- Calcitonin Salmon (by Hikma Pharmaceuticals Usa Inc.)
- Calcitonin Salmon (by Par Health Usa, Llc)
- Calcitonin Salmon (by Sagent Pharmaceuticals)
- Miacalcin (by Mylan Institutional Llc)
- Miacalcin (by Mylan Institutional Llc)
- Miacalcin (by Mylan Institutional Llc)
- View full label-group details →
- Drug class
- Calcitonin
- Dosage form
- Injection, Solution
- Routes
- Intramuscular
- Subcutaneous
- Prescription status
- Rx (prescription)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2024
- Label revision date
- July 30, 2025
- FDA Insert
- Prescribing information, PDF file
- Active ingredient
- Calcitonin Salmon 200 [USP'U]/1 mL
- Other brand names
- Calcitonin Salmon (by Amneal Pharmaceuticals Llc)
- Calcitonin Salmon (by Apotex Corp.)
- Calcitonin Salmon (by Dr. Reddy's Laboratories, Inc.)
- Calcitonin Salmon (by Endo Usa, Inc.)
- Calcitonin Salmon (by Fresenius Kabi Usa, Llc)
- Calcitonin Salmon (by Hikma Pharmaceuticals Usa Inc.)
- Calcitonin Salmon (by Par Health Usa, Llc)
- Calcitonin Salmon (by Sagent Pharmaceuticals)
- Miacalcin (by Mylan Institutional Llc)
- Miacalcin (by Mylan Institutional Llc)
- Miacalcin (by Mylan Institutional Llc)
- View full label-group details →
- Drug class
- Calcitonin
- Dosage form
- Injection, Solution
- Routes
- Intramuscular
- Subcutaneous
- Prescription status
- Rx (prescription)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2024
- Label revision date
- July 30, 2025
- Manufacturer
- Cipla USA Inc.
- Registration number
- ANDA213766
- NDC root
- 69097-770
- FDA Insert
- Prescribing information, PDF file
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Drug Overview
Calcitonin-salmon injection is a synthetic form of a hormone called calcitonin, which is naturally produced by the thyroid gland in mammals and by certain glands in birds and fish. This medication is used to treat conditions such as Paget's disease of bone, hypercalcemia (high levels of calcium in the blood), and postmenopausal osteoporosis when other treatments are not suitable. It works by inhibiting the process of bone resorption, which helps to lower calcium levels in the blood and can reduce bone loss.
The injection is provided in a sterile solution and is administered either under the skin (subcutaneous) or into a muscle (intramuscular). Each milliliter contains 200 USP Units of calcitonin-salmon. By decreasing the activity of cells that break down bone, calcitonin-salmon can help manage symptoms associated with these bone-related conditions.
Uses
Calcitonin salmon injection is used to help manage certain bone-related conditions. If you have symptomatic Paget's disease of bone and other treatments aren't suitable for you, this medication can be an option. It is also effective in treating hypercalcemia, a condition where there is too much calcium in the blood. Additionally, if you are postmenopausal and other treatments for osteoporosis are not appropriate, calcitonin salmon can be considered, although it’s important to note that it has not been shown to reduce fractures in these cases.
Dosage and Administration
If you have symptomatic Paget's disease of bone or postmenopausal osteoporosis, you will need to take 100 USP Units of the medication each day. It's important to make sure you are also getting enough calcium and vitamin D in your diet to support your bone health.
For hypercalcemia (high levels of calcium in the blood), the treatment starts with a dose of 4 USP Units for every kilogram of your body weight, taken every 12 hours. If you don’t see any improvement after 1 to 2 days, your doctor may increase the dose to 8 USP Units per kilogram, still every 12 hours. If there’s still no improvement after another 2 days, the dose may be increased again to 8 USP Units per kilogram, but this time every 6 hours. Always follow your healthcare provider's instructions for the best results.
What to Avoid
It's important to be aware of certain situations where you should not use this medication. If you have a known hypersensitivity (an allergic reaction) to calcitonin-salmon or any of the ingredients in the medication, you should avoid taking it.
Additionally, this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Be cautious and follow your healthcare provider's instructions closely to prevent any issues related to dependence (a condition where your body becomes reliant on a substance). Always consult with your doctor if you have any concerns or questions about using this medication.
Side Effects
You may experience some common side effects when using this medication, including nausea (which may or may not be accompanied by vomiting) and inflammation at the injection site, both occurring in about 10% of users. Flushing of the face or hands may also happen, affecting 2% to 5% of people.
There are also serious side effects to be aware of. Some individuals may have severe allergic reactions, including potentially life-threatening anaphylaxis (a severe allergic reaction). It's important to consider skin testing if you have a history of hypersensitivity to calcitonin-salmon. Other serious concerns include low calcium levels (hypocalcemia), an increased risk of certain cancers based on clinical studies, and the possibility of developing antibodies that could reduce the effectiveness of the treatment. If you have any concerns about these side effects, please discuss them with your healthcare provider.
Warnings and Precautions
You should be aware of some important warnings and precautions when using this medication. Serious allergic reactions, including life-threatening anaphylaxis, have been reported. If you have a history of allergies to calcitonin-salmon, your doctor may recommend skin testing before starting treatment. Additionally, low calcium levels (hypocalcemia) can occur, so it's essential to ensure you are getting enough calcium and vitamin D in your diet.
There is also a potential increased risk of cancer (malignancy) associated with this treatment, as suggested by a review of multiple clinical trials. Furthermore, some patients may develop antibodies against calcitonin-salmon, which could reduce the effectiveness of the treatment.
If you experience any severe allergic reactions, such as difficulty breathing or swelling of the face and throat, seek emergency help immediately. You should also stop using the medication and contact your doctor if you notice any unusual symptoms or if you have concerns about your treatment. Regular lab tests may be necessary to monitor your health while on this medication.
Overdose
If you take too much calcitonin salmon injection, you might experience symptoms like nausea and vomiting, especially if you receive a dose of 1000 International Units. In some cases, an overdose could lead to a condition called hypocalcemic tetany, which involves muscle spasms due to low calcium levels in your blood.
If you suspect an overdose, it’s important to seek medical help immediately. Medical professionals may need to provide calcium through an injection to counteract the effects of the overdose. While short-term doses of 32 International Units per kg per day have not shown significant adverse effects, there is not enough information on the long-term effects of high doses. Always consult your healthcare provider if you have concerns about your medication.
Pregnancy Use
If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been clearly outlined.
Given this lack of information, it is advisable to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.
Lactation Use
If you are breastfeeding or planning to breastfeed, it's important to know that there is currently no information available about whether calcitonin-salmon is present in human milk or how it might affect your child or your milk production. However, studies in rats have shown that calcitonin can inhibit lactation, which means it may impact your ability to produce milk.
When considering the use of calcitonin-salmon injection, weigh the developmental and health benefits of breastfeeding against your need for this medication and any potential risks to your baby. Always consult with your healthcare provider to make the best decision for you and your child.
Pediatric Use
When considering this medication for your child, it's important to know that its safety and effectiveness in children have not been established. This means that there hasn't been enough research to confirm that it works well or is safe for pediatric patients (children and adolescents). Always consult with your child's healthcare provider to discuss any concerns and to explore the best treatment options for their specific needs.
Geriatric Use
When considering calcitonin salmon injection for older adults, it's important to note that clinical studies did not include enough participants aged 65 and older to fully understand how they might respond compared to younger individuals. However, based on other clinical experiences, no significant differences in responses have been reported between older and younger patients.
For older adults, healthcare providers typically recommend starting at the lower end of the dosing range. This cautious approach is due to the higher likelihood of decreased liver (hepatic), kidney (renal), or heart (cardiac) function, as well as the presence of other health conditions or medications. Always consult with your healthcare provider to ensure the safest and most effective treatment plan tailored to your needs.
Renal Impairment
If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.
Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.
Hepatic Impairment
If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.
Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.
Drug Interactions
It's important to talk to your healthcare provider about all the medications you are taking, including calcitonin-salmon and lithium. When these two are used together, calcitonin-salmon can increase the amount of lithium that your body clears through urine, which may lower the levels of lithium in your blood. This means that your doctor might need to adjust your lithium dose to ensure it remains effective.
Since there are no other specific drug or lab test interactions noted, it's still a good practice to keep your healthcare provider informed about any changes in your medication or health status. This helps ensure your treatment is safe and effective.
Storage and Handling
To ensure the best performance of your product, store it in the refrigerator at a temperature between 2° to 8°C (36° to 46°F). It's important to keep it protected from freezing, as extreme cold can damage the product.
When handling the product, always do so with care to maintain its integrity and effectiveness. Following these storage and handling guidelines will help ensure your product remains safe and effective for use.
Additional Information
You should consider periodic urine tests to monitor your health while using calcitonin-salmon. If you have a suspected allergy to calcitonin-salmon, it's advisable to undergo skin testing with a diluted solution before starting treatment. Your healthcare provider may refer you to an allergist for this testing.
Recent studies have indicated that patients treated with calcitonin-salmon may have a higher incidence of certain cancers compared to those receiving a placebo. This increased risk cannot be ruled out for long-term use of the medication. It's important to weigh the potential benefits against these risks with your healthcare provider. Additionally, some patients may develop antibodies to calcitonin-salmon, which could affect treatment effectiveness if you initially respond but later do not. Lastly, while some changes in urine sediment were observed in studies, these were not linked to any lasting kidney issues.
FAQ
What is Calcitonin-salmon injection?
Calcitonin-salmon injection is a synthetic polypeptide hormone used for treating conditions like Paget's disease, hypercalcemia, and postmenopausal osteoporosis.
What are the indications for using Calcitonin-salmon injection?
It is indicated for the treatment of symptomatic Paget's disease of bone, hypercalcemia, and postmenopausal osteoporosis when alternative treatments are not suitable.
What are the common side effects of Calcitonin-salmon injection?
Common side effects include nausea, injection site inflammation, and flushing of the face or hands.
Are there any serious adverse reactions associated with Calcitonin-salmon injection?
Yes, serious reactions can include hypersensitivity reactions, hypocalcemia, and an increased risk of malignancies.
How should Calcitonin-salmon injection be stored?
Store Calcitonin-salmon injection in a refrigerator between 2° to 8°C (36° to 46°F) and protect it from freezing.
What should I do if I suspect a hypersensitivity to Calcitonin-salmon?
Consider skin testing prior to treatment if you have suspected hypersensitivity to Calcitonin-salmon.
Is Calcitonin-salmon injection safe during pregnancy?
There is no specific information regarding the safety of Calcitonin-salmon injection during pregnancy.
Can Calcitonin-salmon injection affect breastfeeding?
Calcitonin has been shown to inhibit lactation in rats, but there is no information on its effects in human milk.
What are the dosing recommendations for symptomatic Paget's disease?
The recommended dose is 100 USP Units daily, ensuring adequate calcium and vitamin D intake.
What should I do if I experience hypocalcemia while using Calcitonin-salmon?
Ensure adequate intake of calcium and vitamin D, and consult your healthcare provider.
Packaging Info
The table below lists all NDC Code configurations of Calcitonin Salmon, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Injection, Solution | 200 [USP'U]/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
FDA Insert (PDF)
This is the full prescribing document for Calcitonin Salmon, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.
Description
Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish. Calcitonin-salmon injection, Synthetic is a synthetic polypeptide consisting of 32 amino acids arranged in the same linear sequence as calcitonin derived from salmon. It is available as a sterile solution for subcutaneous or intramuscular injection, with each milliliter containing 200 USP Units of calcitonin-salmon. The formulation includes the following inactive ingredients per mL: acetic acid, USP (2.25 mg), phenol, USP (5.0 mg), sodium acetate trihydrate, USP (2.0 mg), sodium chloride, USP (7.5 mg), and water for injection, USP.
Uses and Indications
Calcitonin salmon injection is indicated for the treatment of symptomatic Paget's disease of bone when alternative treatments are not suitable. It is also indicated for the management of hypercalcemia. Additionally, this drug is indicated for the treatment of postmenopausal osteoporosis in cases where alternative treatments are not appropriate; however, the efficacy of fracture reduction has not been demonstrated.
There are no teratogenic or nonteratogenic effects associated with this medication.
Dosage and Administration
For the treatment of symptomatic Paget's disease of bone, the recommended dosage is 100 USP Units administered daily. It is essential to ensure that patients receive adequate calcium and vitamin D intake during the course of treatment.
In cases of hypercalcemia, the initial dosage should be 4 USP Units per kilogram of body weight, administered every 12 hours. If there is no observed improvement within 1 to 2 days, the dosage may be increased to 8 USP Units per kilogram every 12 hours. Should there still be no improvement after an additional 2 days, the dosage can be further escalated to 8 USP Units per kilogram every 6 hours.
For the management of postmenopausal osteoporosis, the recommended dosage is also 100 USP Units daily, with an emphasis on ensuring adequate calcium and vitamin D intake.
Contraindications
Use of this product is contraindicated in patients with hypersensitivity to calcitonin-salmon or any of the excipients. Due to the potential for severe allergic reactions, administration in these individuals may pose significant health risks.
Warnings and Precautions
Serious hypersensitivity reactions, including instances of fatal anaphylaxis, have been reported in patients receiving calcitonin-salmon. It is advisable to consider skin testing prior to initiating treatment in individuals with a suspected hypersensitivity to this agent.
Patients should be monitored for hypocalcemia, which has been documented in some cases. To mitigate this risk, it is essential to ensure that patients have an adequate intake of calcium and vitamin D.
Additionally, a meta-analysis encompassing 21 clinical trials has indicated a potential increase in the risk of overall malignancies among patients treated with calcitonin-salmon. Healthcare professionals should remain vigilant regarding this risk and consider appropriate patient counseling and monitoring.
Furthermore, the development of circulating antibodies to calcitonin-salmon may occur, potentially leading to a diminished therapeutic response. Regular assessment of treatment efficacy is recommended to identify any loss of response that may necessitate a reevaluation of the treatment regimen.
Side Effects
Patients receiving calcitonin-salmon may experience a range of adverse reactions, which can be categorized into common and serious events.
Common adverse reactions observed in clinical trials include nausea with or without vomiting, which occurred in approximately 10% of patients, and injection site inflammation, also reported in about 10% of participants. Flushing of the face or hands was noted in 2% to 5% of subjects.
Serious adverse reactions have been documented and warrant careful consideration. Notably, serious hypersensitivity reactions, including reports of fatal anaphylaxis, have been reported. It is advisable to consider skin testing prior to treatment in patients with suspected hypersensitivity to calcitonin-salmon. Additionally, hypocalcemia has been reported; therefore, ensuring adequate intake of calcium and vitamin D is essential for patients undergoing treatment. A meta-analysis of 21 clinical trials indicates an increased risk of overall malignancies in patients treated with calcitonin-salmon. Furthermore, circulating antibodies to calcitonin-salmon may develop, potentially leading to a loss of response to treatment.
Other important notes include the potential for hypersensitivity to calcitonin-salmon or any of its excipients. The pharmacologic actions of calcitonin-salmon injection suggest that hypocalcemic tetany could occur in cases of overdose; thus, provisions for parenteral administration of calcium should be readily available. A dose of calcitonin-salmon at 1000 International Units subcutaneously may lead to nausea and vomiting, while doses of 32 International Units per kg per day for 1 to 2 days have shown no other adverse effects. However, data on chronic high-dose administration are insufficient to assess toxicity comprehensively.
Drug Interactions
Concomitant use of calcitonin-salmon and lithium may result in a pharmacokinetic interaction characterized by a reduction in plasma lithium concentrations. This effect is attributed to increased urinary clearance of lithium when both agents are administered together. Therefore, it is advisable to monitor lithium levels closely and consider adjusting the lithium dosage as necessary to maintain therapeutic efficacy.
No additional drug or laboratory test interactions have been reported.
Packaging & NDC
The table below lists all NDC Code configurations of Calcitonin Salmon, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Injection, Solution | 200 [USP'U]/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Therefore, the use of this medication in children, infants, and adolescents should be approached with caution, and healthcare professionals are advised to consider the lack of data when prescribing to this population.
Geriatric Use
Clinical studies of calcitonin salmon injection did not include a sufficient number of subjects aged 65 years and older to determine whether they respond differently from younger subjects. However, other reported clinical experience has not identified significant differences in responses between elderly patients and younger patients.
In general, dose selection for geriatric patients should be approached with caution. It is advisable to start at the low end of the dosing range, taking into account the increased likelihood of decreased hepatic, renal, or cardiac function, as well as the presence of concomitant diseases or other drug therapies. Monitoring for efficacy and safety is recommended to ensure appropriate management of treatment in this population.
Pregnancy
There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the context of the patient's clinical situation. Women of childbearing potential should be counseled on the importance of effective contraception while receiving this medication.
Lactation
There is no information available regarding the presence of calcitonin-salmon in human milk, nor are there data on its effects on breastfed infants or on milk production. However, calcitonin has been shown to inhibit lactation in animal studies involving rats.
When considering the use of calcitonin-salmon injection in lactating mothers, it is important to weigh the developmental and health benefits of breastfeeding against the mother's clinical need for the medication. Additionally, potential adverse effects on the breastfed infant from calcitonin-salmon injection or from the underlying maternal condition should be taken into account.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.
Overdosage
In cases of overdose with calcitonin salmon injection, healthcare professionals should be vigilant for potential symptoms and prepared to manage them appropriately.
Potential Symptoms of Overdosage The pharmacologic actions of calcitonin salmon injection indicate that overdose may lead to hypocalcemic tetany. Additionally, administration of a dose of 1000 International Units subcutaneously may result in nausea and vomiting. It is important to note that doses of 32 International Units per kg per day for a duration of 1 to 2 days have not demonstrated any other adverse effects. However, data regarding the toxicity associated with chronic high-dose administration remain insufficient.
Management of Overdosage In the event of an overdose, provisions for parenteral administration of calcium should be readily available to counteract the effects of hypocalcemia. Healthcare professionals are advised to monitor the patient closely and provide supportive care as necessary. Given the potential for nausea and vomiting, appropriate symptomatic treatment should also be considered.
Overall, while the immediate effects of overdose can be managed, further research is needed to fully understand the implications of chronic high-dose exposure to calcitonin salmon.
Nonclinical Toxicology
The incidence of pituitary adenomas was increased in rats following one and two years of subcutaneous exposure to synthetic calcitonin-salmon. The relevance of this finding to humans remains uncertain, as pituitary adenomas are commonly observed in aging rats. Notably, these adenomas did not progress to metastatic tumors, and no other treatment-related neoplasms were identified. Furthermore, neoplasms associated with synthetic calcitonin-salmon were not observed in mice after two years of dosing.
In male Fisher 344 rats and female Sprague Dawley rats, an increase in the incidence of pituitary adenomas was the only significant neoplastic finding after subcutaneous dosing with calcitonin-salmon. In female Sprague Dawley rats, the incidence of pituitary adenomas after two years was notably high across all treatment groups (ranging from 80% to 92%, including control groups), making it difficult to distinguish a treatment-related effect from the natural background incidence. The lowest dose in male Sprague Dawley rats that exhibited an increased incidence of pituitary adenomas after two years of dosing was 1.7 International Units/kg/day, which is approximately one-sixth of the maximum recommended subcutaneous dose in humans (100 International Units/day) when adjusted for body surface area. These findings suggest that calcitonin-salmon may reduce the latency period for the development of non-functioning pituitary adenomas.
No evidence of carcinogenic potential was observed in male or female mice dosed subcutaneously for two years with synthetic calcitonin-salmon at doses up to 800 International Units/kg/day. This dose is approximately 39 times the maximum recommended subcutaneous dose in humans (100 International Units/day) based on body surface area conversion.
Synthetic calcitonin-salmon was tested for mutagenicity and found to be negative in assays using Salmonella typhimurium (five strains) and Escherichia coli (two strains), both with and without rat liver metabolic activation. Additionally, it was not clastogenic in a chromosome aberration test conducted in Chinese Hamster V79 cells, nor was there evidence of clastogenicity in the in vivo mouse micronucleus test.
The effects of calcitonin-salmon on fertility have not been evaluated in animal studies.
Postmarketing Experience
Postmarketing experience has identified a potential increase in the risk of malignancy associated with the use of calcitonin salmon injection. This information is derived from reports received voluntarily and through surveillance programs.
Patient Counseling
Healthcare providers should instruct patients and caregivers on the proper sterile injection technique for administering calcitonin salmon injection. It is essential to emphasize the importance of proper disposal of needles to ensure safety and prevent injury.
Patients should be informed about the potential increase in the risk of malignancy associated with the use of this medication. It is crucial for healthcare providers to discuss this risk openly with patients to ensure they are fully informed.
For patients diagnosed with postmenopausal osteoporosis or Paget's disease of bone, healthcare providers should advise them to maintain an adequate intake of calcium and vitamin D. Specifically, patients should aim for at least 1000 mg of elemental calcium and 400 International Units of vitamin D per day to support their bone health.
Additionally, healthcare providers must instruct patients to seek emergency medical assistance or go to the nearest hospital emergency room immediately if they experience any signs or symptoms of a serious allergic reaction. Prompt action in such cases is vital for patient safety.
Storage and Handling
The product is supplied in a refrigerated state and must be stored at temperatures between 2° to 8°C (36° to 46°F). It is essential to protect the product from freezing to maintain its integrity and efficacy. Proper handling and storage conditions are critical to ensure the product remains within the specified temperature range.
Additional Clinical Information
Periodic examinations of urine sediment should be considered for patients undergoing treatment with calcitonin-salmon. For those with suspected hypersensitivity to calcitonin-salmon, clinicians may recommend skin testing using a dilute, sterile solution of the injection, and referrals to allergists may be appropriate for this purpose.
Postmarketing experience indicates that in a meta-analysis of 21 randomized, controlled clinical trials, the incidence of malignancies was higher in calcitonin-salmon-treated patients (4.1%) compared to those receiving placebo (2.9%), suggesting a potential increased risk of malignancies with calcitonin-salmon treatment. Long-term administration via subcutaneous, intramuscular, or intravenous routes may also carry this risk. Clinicians should weigh the benefits against potential risks for each patient. Additionally, circulating antibodies to calcitonin-salmon have been observed, which may affect treatment response. In studies involving young adult volunteers, coarse granular casts and renal tubular epithelial cell casts were noted in urine samples after administration of injectable calcitonin-salmon, although no other renal abnormalities were detected, and urine sediment normalized after discontinuation of the drug.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Calcitonin Salmon as submitted by Cipla USA Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.