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Miacalcin
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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 Cipla Usa Inc.)
- 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)
- 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 2022
- Label revision date
- August 15, 2021
- 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 Cipla Usa Inc.)
- 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)
- 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 2022
- Label revision date
- August 15, 2021
- Manufacturer
- Mylan Institutional LLC
- Registration number
- NDA017808
- NDC root
- 72078-038
- FDA Insert
- Prescribing information, PDF file
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Drug Overview
Miacalcin (calcitonin salmon, USP) 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 available as an injection and contains calcitonin salmon, which is a polypeptide made up of 32 amino acids. It works primarily on bone and has effects on the kidneys and gastrointestinal tract, acting as a calcitonin receptor agonist. This means it binds to specific receptors in the body to help regulate calcium levels and bone metabolism.
Miacalcin is used to treat conditions such as Paget’s disease of bone, hypercalcemia (high calcium levels in the blood), and postmenopausal osteoporosis when other treatments are not suitable. It is important to note that while Miacalcin has similar effects to natural calcitonin, it is more potent and has a longer duration of action.
Uses
You may be prescribed this medication for several specific health conditions. It is used to treat symptomatic Paget’s disease of bone, particularly when other treatments are not suitable for you. Additionally, it can help manage hypercalcemia, which is a condition characterized by high levels of calcium in the blood.
If you are a postmenopausal woman and other treatments are not appropriate, this medication may also be used to treat osteoporosis, a condition that weakens bones. However, it's important to note that the effectiveness of this medication in reducing fractures has not been demonstrated. Always consult with your healthcare provider to determine the best treatment options for your situation.
Dosage and Administration
If you are being treated for 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 treatment.
For hypercalcemia (high levels of calcium in the blood), your starting dose will be 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 an additional 2 days, the dose may be further increased to 8 USP Units per kilogram every 6 hours. Always follow your healthcare provider's instructions closely to ensure the best results.
What to Avoid
If you are allergic to calcitonin salmon or any of its ingredients, you should not use this medication. It's important to be aware that this drug is classified as a controlled substance, which means it has the potential for abuse or misuse. Additionally, using this medication can lead to dependence (a condition where your body becomes reliant on a substance). Always consult with your healthcare provider to ensure that this treatment is safe for you, especially if you have any concerns about allergies or substance use.
Side Effects
You may experience some common side effects when using this medication, including nausea (which may occur with or without vomiting) and inflammation at the injection site, both affecting about 10% of users. Flushing of the face or hands may occur in 2% to 5% of cases.
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. Additionally, low calcium levels (hypocalcemia) can occur, so ensure you are getting enough calcium and vitamin D. There is also a noted increased risk of certain cancers in patients treated with calcitonin salmon, and some may develop antibodies that could reduce the effectiveness of the treatment. If you experience any unusual symptoms, please consult 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, your body may develop antibodies against calcitonin salmon, which could reduce the effectiveness of the treatment over time.
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.
Overdose
If you take too much of Miacalcin injection, you might experience symptoms like nausea and vomiting, especially if you receive a high dose. In rare cases, an overdose could lead to a condition called hypocalcemic tetany, which involves muscle spasms due to low calcium levels in your blood. It's important to have calcium available for treatment if an overdose occurs.
If you suspect an overdose, seek medical help immediately. Be aware of the signs, such as severe nausea or unusual muscle spasms. Always consult with a healthcare professional if you have concerns about your dosage or experience any adverse effects.
Pregnancy Use
There are currently no studies involving Miacalcin injection in pregnant women, so we cannot determine if it poses a risk for birth defects or miscarriage. However, animal studies have shown that when pregnant rabbits received doses of calcitonin salmon significantly higher than the recommended human dose, there was a decrease in fetal birth weights. In contrast, no negative developmental effects were observed in rats given much higher doses during pregnancy.
It's important to note that in the general U.S. population, the estimated risk of major birth defects in recognized pregnancies is between 2-4%, and the risk of miscarriage is about 15-20%. While some animal studies indicate potential risks, no embryo or fetal toxicities were reported in rats at certain doses. If you are pregnant or planning to become pregnant, it's essential to discuss any medications with your healthcare provider to weigh the benefits and risks.
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 (Miacalcin injection) 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 affect your ability to produce milk.
When considering the use of Miacalcin, weigh the developmental and health benefits of breastfeeding against your need for this medication and any potential risks it may pose 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 Miacalcin 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 elderly patients, 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 plan.
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, so don't hesitate to ask questions or express any concerns you may have.
Drug Interactions
It's important to be aware that if you are taking calcitonin salmon along with lithium, it can affect how lithium works in your body. Specifically, calcitonin salmon may increase the amount of lithium that your body gets rid of through urine, which can lower the levels of lithium in your blood. This means that your healthcare provider might need to adjust your lithium dose to ensure it remains effective.
Always discuss any medications you are taking with your healthcare provider, including over-the-counter drugs and supplements. They can help you understand potential interactions and make necessary adjustments to your treatment plan for your safety and well-being.
Storage and Handling
To ensure the best performance and safety of your product, store it in a refrigerator at a temperature between 2° to 8°C (36° to 46°F). It's important to keep the product protected from freezing, as extreme cold can damage it.
When handling the product, always maintain a clean environment to avoid contamination. Following these storage and handling guidelines will help ensure the product remains effective and safe for use.
Additional Information
No further information is available.
FAQ
What is Miacalcin?
Miacalcin is a synthetic injection of calcitonin salmon, a polypeptide hormone used for treating conditions like Paget’s disease, hypercalcemia, and postmenopausal osteoporosis.
How is Miacalcin administered?
Miacalcin is provided in a sterile solution for subcutaneous or intramuscular injection.
What are the indications for using Miacalcin?
Miacalcin is indicated for symptomatic Paget’s disease of bone, hypercalcemia, and postmenopausal osteoporosis when alternative treatments are not suitable.
What are the common side effects of Miacalcin?
Common side effects include nausea with or without vomiting, injection site inflammation, and flushing of the face or hands.
What serious adverse reactions can occur with Miacalcin?
Serious reactions may include hypersensitivity reactions, hypocalcemia, and an increased risk of malignancies.
Is Miacalcin safe to use during pregnancy?
There are no studies in pregnant women, but animal studies suggest it may decrease fetal birth weights. Consult your doctor for advice.
Can Miacalcin be used while breastfeeding?
There is no information on the presence of calcitonin salmon in human milk or its effects on breastfeeding. Discuss with your healthcare provider.
What should I do if I experience an allergic reaction to Miacalcin?
If you experience serious hypersensitivity reactions, including anaphylaxis, seek immediate medical attention.
What are the dosing recommendations for Paget’s disease?
For symptomatic Paget’s disease, the recommended dose is 100 USP Units daily, ensuring adequate calcium and vitamin D intake.
What precautions should be taken when using Miacalcin?
The need for continued therapy should be re-evaluated periodically due to a possible association with malignancy.
Packaging Info
The table below lists all NDC Code configurations of Miacalcin (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 Miacalcin, 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 produced by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland in birds and fish. Miacalcin (calcitonin salmon, USP) Injection, Synthetic is a synthetic polypeptide consisting of 32 amino acids arranged in the same linear sequence as calcitonin derived from salmon. This formulation is supplied as a sterile solution intended for subcutaneous or intramuscular injection, with each milliliter containing 200 USP Units of calcitonin salmon.
The inactive ingredients per milliliter include acetic acid (2.25 mg), phenol (5 mg), sodium acetate trihydrate (2 mg), sodium chloride (7.5 mg), and water for injection. The activity of Miacalcin injection is expressed in International Units, determined through bioassay in comparison with the International Reference Preparation of calcitonin salmon for Bioassay, as distributed by the National Institute for Biological Standards and Control, Holly Hill, London.
Uses and Indications
This drug is indicated for the treatment of symptomatic Paget’s disease of bone when alternative treatments are not suitable. It is also indicated for the treatment of hypercalcemia. Additionally, this drug is indicated for the treatment of postmenopausal osteoporosis in cases where alternative treatments are not suitable; however, the efficacy for fracture reduction has not been demonstrated.
There are no specific teratogenic or nonteratogenic effects associated with this drug.
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 improvement observed 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 a strong 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 documented in patients receiving calcitonin salmon. It is advisable to consider conducting skin testing prior to initiating treatment in individuals with a suspected hypersensitivity to this agent.
Patients should be monitored for hypocalcemia, which has been reported in some cases. To mitigate this risk, it is essential to ensure that patients have an adequate intake of calcium and vitamin D.
Furthermore, 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 when prescribing this medication.
Additionally, 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 reported and warrant careful consideration. Serious hypersensitivity reactions, including fatal anaphylaxis, have been documented. 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 Miacalcin injection suggest that hypocalcemic tetany could occur in cases of overdose; thus, provisions for parenteral administration of calcium should be readily available. Notably, a dose of 1000 International Units of calcitonin salmon administered 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 adequately assess toxicity.
Drug Interactions
Concomitant administration of calcitonin salmon and lithium may result in a reduction of plasma lithium concentrations. This interaction is attributed to the increased urinary clearance of lithium when calcitonin salmon is used concurrently. Therefore, it is advisable to monitor lithium levels closely and consider adjusting the lithium dosage as necessary to maintain therapeutic efficacy.
Packaging & NDC
The table below lists all NDC Code configurations of Miacalcin (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 until further data is available.
Geriatric Use
Clinical studies of Miacalcin injection did not include a sufficient number of subjects aged 65 years and older to determine whether this population responds 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. Careful monitoring of these patients is recommended to ensure safety and efficacy.
Pregnancy
There are no studies with Miacalcin injection in pregnant women to inform a drug-associated risk for birth defects or miscarriage. Animal reproduction studies have shown that subcutaneous administration of calcitonin salmon to pregnant rabbits during organogenesis at doses 4 to 18 times the recommended parenteral human dose resulted in decreased fetal birth weights. However, no adverse developmental outcomes were observed in rats receiving subcutaneous calcitonin salmon at doses up to 9 times the recommended human parenteral dose based on body surface area.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. While calcitonin salmon has been associated with decreased fetal birth weights in rabbits, no embryo/fetal toxicities related to Miacalcin were reported in rats at maternal subcutaneous daily doses of up to 80 International Units/kg/day from gestation days 6 to 15.
Given the lack of human data and the findings from animal studies, healthcare professionals should weigh the potential risks and benefits when considering the use of Miacalcin in pregnant patients.
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 in lactating mothers. However, calcitonin has been shown to inhibit lactation in animal studies involving rats.
When considering the use of Miacalcin 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 Miacalcin injection or from the underlying maternal condition should be taken into account.
Renal Impairment
Patients with renal impairment have not been specifically addressed in terms of dosage adjustments, special monitoring, or safety considerations. As such, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, given the absence of detailed guidance in the prescribing information. Regular monitoring of renal function may be prudent in these patients to ensure safety and efficacy.
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 overdosage with Miacalcin injection, the pharmacologic actions indicate that hypocalcemic tetany may occur. It is essential that provisions for the parenteral administration of calcium are readily available to manage this potential complication effectively.
Administration of calcitonin salmon at a dose of 1000 International Units subcutaneously may lead to gastrointestinal symptoms, specifically nausea and vomiting. However, doses of 32 International Units per kg per day for a duration of 1 to 2 days have not demonstrated any significant adverse effects. It is important to note that data regarding the toxicity of chronic high-dose administration remain insufficient, necessitating caution and further investigation in such scenarios.
Healthcare professionals should monitor patients closely for symptoms of overdose and be prepared to initiate appropriate management strategies, including the administration of calcium as needed.
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, the only significant neoplastic finding was an increased incidence of pituitary adenomas after one year of dosing, as well as in male Sprague Dawley rats dosed for one and two years. 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 resulted in 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 synthetic 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 has been tested for mutagenicity and was 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 indicated a potential increase in the risk of malignancy associated with the use of the product. This information has been reported voluntarily by patients and healthcare professionals, as well as through surveillance programs. It is important for healthcare providers to inform patients of this potential risk when considering treatment options.
Patient Counseling
Healthcare providers should instruct patients and caregivers on the proper sterile injection technique for Miacalcin injection. It is essential to emphasize the importance of disposing of needles safely to prevent any potential harm.
Providers should inform patients about the potential increase in the risk of malignancy associated with the use of this medication. This information is crucial for patients to make informed decisions regarding their treatment.
For patients diagnosed with postmenopausal osteoporosis or Paget’s disease of bone, it is important to 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 should 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 effective throughout its shelf life.
Additional Clinical Information
No further data are available.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Miacalcin as submitted by Mylan Institutional LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.