For nasal dosage form (spray): For postmenopausal osteoporosis: Adults200 International Units (IU) or 1 spray into one nostril per day. << - For the treatment of Paget's disease, only in patients who do not respond to alternative treatments or for whom such treatments are not suitable, for example those with severe renal impairment. Hypersensitivity Reactions: Serious hypersensitivity reactions have been reported in patients receiving Miacalcin injection, e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis. The recommended starting dose is 100 IU every 6 to 8 hours by subcutaneous or intramuscular injection. General disorders and administration site conditions. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For additional instructions see sections 6.3 and 6.6. [52559] Per treatment guidelines for Paget's disease, the use of injectable calcitonin-salmon leads to partial radiographic healing of lytic lesions, but most patients do not achieve normalization of bone turnover, and thus calcitonin has limited use versus newer, more effective agents (i.e., bisphosphonates). Instruct patients to seek medical care if symptoms of hypocalcemia develop. [27980][52559] [57624], Calcitonin-salmon should be used during pregnancy only if the potential benefit justifies the use versus potential risks to the patient or fetus. >> If patient or caregiver is to administer parenteral calcitonin, provide careful instructions on proper administration methods, including aseptic technique. With intranasal therapy, rhinitis, nasal symptoms, back pain. Reports of serious hypersensitivity reactions with injectable calcitonin-salmon have also been reported, including reports of death attributed to anaphylaxis. [27980] [52559] [57624]Calcitonin is a hypocalcemic hormone whose effects are generally opposite those of parathyroid hormone (PTH). \Mu}I'wP{|vq wW7_=0Z&F0P13Mhx.='rU 8OIm0Kl{xA#{(/GOh\k j)/^z0r[q kSY+LOuC0 | For the treatment of hypercalcemia, vitamin D preparations should be avoided. %%EOF Calcitonin helps maintain calcium homeostasis. hb```M~ cc`aq@a/O(C" H82t*\S, j2UFMzCD(ztZh PZa0J i`1@ To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location one that is up and away and out of their sight and reach. Resume the regular dosing schedule at the beginning of the next week. Treatment should be discontinued once the patient has responded and symptoms have resolved. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels. x][o~_93EK! For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. The recommended dosage is 100 IU daily or 50 IU twice daily administered subcutaneously or intramuscularly. Healthcare providers may wish to refer patients who require skin testing to an allergist. Known hypersensitivity to calcitonin salmon. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. Drug class: Antiparathyroid Agents 11 0 obj By using this Site you agree to the following, By using this Site you agree to the following, Miacalcin injection prescribing information. Discard the bottle after 30 doses. When sprayed into the nose, miacalcin is quickly absorbed into the blood stream. Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. ADVERSE REACTIONS: The 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%). Correct hypocalcemia and any other disorders affecting mineral metabolism (e.g., vitamin D deficiency) before administration of calcitonin. Although calcitonin may help relieve acute back pain associated with a recent osteoporotic vertebral compression fracture, one metanalysis found that there is no sufficient data for effectiveness against chronic pain associated with older vertebral fracture. /ExtGState << Discard spray pump after 30 actuations, since the correct drug dose per actuation cannot be assured if used for additional doses. The absence of mineralisation defect with calcitonin has been demonstrated by bone histomorphometric studies both in man and in animals. The majority of patients in whom nasal abnormalities were noted also reported nasal complaints/symptoms as adverse events. Brand names: Fortical, Miacalcin [63474] Calcitonin 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).[52559]. /CreationDate (D:20210907165018-04'00') Advise patients using calcitonin nasal spray to notify their clinician if nasal irritation develops. 2021. Duration of treatment should not normally exceed 3 months due to evidence of an increased risk of malignancies with long term calcitonin use. 17 0 obj Therefore, a nasal examination should be performed prior to the start of treatment with nasal calcitonin and at anytime nasal complaints occur. Intravenous, subcutaneous, or intramuscular use. Calcitriol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Each 1 ml solution contains 3.3 mg sodium. Calcitonin is given parenterally (preferably by subcutaneous or intramuscular injection) or intranasally since calcitonin is destroyed in the GI tract. Intranasal RouteAbsorption through the nasal mucosa is rapid, with peak plasma concentrations achieved in 3139 minutes. endobj tqX)I)B>== 9. /ca 1.0 All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. endstream endobj 127 0 obj <>stream endobj For the treatment of hypercalcemia, calcium supplements should be avoided. Possibility of hypocalcemic tetany following parenteral administration; have calcium injection readily available, particularly during first several doses of parenteral calcitonin. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. These studies have not been conducted with Miacalcin Nasal Spray. A detailed skin testing protocol is available from the manufacturers; consult the specific prescribing information for contact information for the skin testing protocol. What special dietary instructions should I follow? Sub-Q injection preferred for patient self-administration. Dihydrotachysterol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. In normal volunteers, bioavailability of the intranasal formulation compared to the parenteral product is 3%, with a range of 0.330.6%. It is not possible to exclude an increased risk when calcitonin-salmon is administered long-term subcutaneously or intramuscularly. * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name, Miacalcin (synthetic; with phenol 5 mg/mL). For the treatment of hypercalcemia, calcium supplements should be avoided. For the full list of excipients, see section 6.1. The addition of 10 mM sodium phosphate buffer . Investigate possibility of antibody formation in any patient who shows initial response but subsequently relapses. To use the sharing features on this page, please enable JavaScript. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels. If your usual dose is every other day, use the missed dose as soon as you remember it, either on the regularly scheduled day or the next day. 1 Development of neutralising antibodies to calcitonin. Maintenance: 50 units (0.25 mL) daily or every other day; higher dosage (100 units daily) appropriate in patients with serious deformity or neurologic involvement. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents. S . Give with supplemental calcium and vitamin D if dietary intake is inadequate. Calcitonin (salmon, synthetic) . [0 /XYZ 69.5999999 Activity of calcitonin salmon expressed in terms of International Units (units). Calcitonin salmon comes as a solution to be injected under the skin (subcutaneously) or into the muscle (intramuscularly). The metabolites lack the specific biological activity of calcitonin. Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures. The recommended treatment duration is 2 weeks and should not exceed 4 weeks in any case due to the association of the increased risk of malignancies and long term calcitonin use. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. /GSa 3 0 R Calcitonin is excreted primarily in the urine as inactive metabolites. 100 International Units IM or subcutaneously once daily. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Depress the pump firmly toward the bottle.Alternate the nostril used for administration each day.To avoid the spread of infection, do not use the sprayer for more than 1 person.Fortical Nasal Spray Storage: After opening, store bottle in use in an upright position at 20 to 25 degrees C (68 to 77 degrees F). S e e f u l l p r e s c r i b i n g i n f o r m a t i o n f o r M I A C A L C I N I N J E C T I O N . Chromium: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For patients with suspected sensitivity to calcitonin, consider skin testing prior to initiating therapy. Minimum effective dosage not established; 100 units every other day may be effective in preserving vertebral BMD. We comply with the HONcode standard for trustworthy health information. We offer this Site AS IS and without any warranties. For the treatment of hypercalcemia, calcium supplements should be avoided. Miacalcin bottle in use: 15-30C, in upright position for up to 35 days. In addition, it appears to be quite beneficial in preventing bone loss after liver transplantation. The mechanism is not clear, but serum lithium concentrations were reduced to 30% of the baseline value in all patients studied, and fell below normal therapeutic ranges. Short-term administration results in a marked transient decrease in the volume and acidity of gastric secretions and the volume and the trypsin and amylase content of pancreatic secretions. >> Talk to your doctor about the possible risks of using this medication for your condition. Calcium Carbonate; Magnesium Hydroxide: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. [0 /XYZ 69.5999999 The dose of lithium may need to be adjusted. The U.S. Pharmacopeia's definition of room-temperature (20-25 C [68-77 F]) was used. 1 0 obj For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Calcitonin markedly reduces bone turnover in conditions with an increased rate of bone resorption such as Paget's disease and acute bone loss due to sudden immobilisation. Calcitonin 50 IU/1 ml solution for injection and infusion . Of the 189 medications listed in AHFS Drug Information 2006 for storage in a . For patients using calcitonin nasal spray, provide careful instruction on storage, pump assembly, priming of pump, and administration. Not known whether calcitonin is distributed into human milk. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. May further titrate. %PDF-1.6 % For additional instructions see sections 6.3 and 6.6. In severe or emergency cases, intravenous infusion with up to 10 IU/kg body weight in 500 ml 0.9% w/v sodium chloride solution may be administered over a period of at least 6 hours. Monitor serum calcium and symptoms of hypocalcemia in patients with a history of hypocalcemia or a mineral metabolism disorder. Patients must therefore be warned that these effects may occur, in which case they should not drive or use machines. Peak effects are observed within 4 hours after parenteral administration. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels. Treatment of postmenopausal osteoporosis in women >5 years postmenopause. Never disregard the medical advice of your physician or health professional, or delay in seeking such advice, because of something you read on this Site. Your doctor may do a skin test before you start calcitonin salmon to make sure you do not have an allergic reaction to it. When suggestions are available use up and down arrows to review and ENTER to select. This information is for use by healthcare professionals, Unit 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB. Use of a drug with proven antifracture efficacy is recommended; experts generally recommend calcitonin as a last-line therapy when other drugs are not effective or tolerated. Qf Ml@DEHb!(`HPb0dFJ|yygs{. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat [see . Calcitonin directly inhibits osteoclasts, binding to plasma membrane receptors and increasing intracellular cyclic adenosine monophosphate (cAMP), as well as interfering with the membrane transport mechanisms of phosphate and calcium. endstream endobj 129 0 obj <>stream Before priming the pump and using a new bottle, allow it to reach room temperature. 12 0 obj hwTTwz0z.0. This has the potential to reduce the total dose delivered to the patient. Healthcare providers may wish to refer patients who require skin testing to an allergist. http://www.upandaway.org. - Treatment of hypercalcemia of malignancy. Dosage >100 units daily usually does not produce an improved response in patients who relapse while receiving calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels. endobj The time to 90% potency (T90) ranged from 32.0 hours to 41.7 hours. We disclaim all responsibility for the professional qualifications and licensing of, and services provided by, any physician or other health providers posting on or otherwise referred to on this Site and/or any Third Party Site. Fortical bottle in use: 2025C, in upright position for up to 30 days. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels. There are no data regarding a potential influence of calcitonin on human fertility. Calcitonin receptor down-regulation may also result in a reduced clinical response in a small percentage of patients following long-term therapy. /Length 18 0 R The actions of calcitonin on bone and its role in normal human bone physiology are still not completely elucidated, although calcitonin receptors have been discovered in osteoclasts and osteoblasts. If there is anything . Hypocalcemia associated with tetany and seizure activity has been reported with calcitonin therapy. For the treatment of hypercalcemia, calcium supplements should be avoided. Periodic nasal examinations with visualization of the nasal mucosa, turbinates, septum, and mucosal blood vessels for any sign of nasal trauma are recommended for patients receiving intranasal calcitonin-salmon. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. The use of calcitonin in combination with bisphosphonates may result in an additive calcium-lowering effect. endobj >> Pharmacotherapeutic group: antiparathyroid hormone, ATC code: H05BA01 (calcitonin, salmon, synthetic). The dosing of Calcitonin should be individualized to the patient's specific requirements. The benefits for the individual patient should be carefully considered against possible risks. Destroyed in GI tract; administer parenterally or intranasally. Carefully consider the benefits for the individual patient against the possible risks. [62369] The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for calcitonin and any potential adverse effects on the breast-fed infant from calcitonin or the underlying maternal condition. Prepared synthetically or using recombinant DNA technology; contains the 32 amino acids in the same linear sequence as occurs in natural calcitonin of salmon origin. Talk with your doctor. Individualize choice of therapy based on potential benefits (with respect to fracture risk reduction) and adverse effects of therapy, patient preferences, comorbidities, and risk factors. 13 0 obj Max: 8 International Units/kg IM or subcutaneously every 6 hours. Nausea, vomiting, flushing and dizziness are known to be dose dependent when calcitonin is administered parenterally. If you log out, you will be required to enter your username and password the next time you visit. . /Type /Page In addition, salmon calcitonin could be administered by intravenous injection after previous rehydration. Results: Of the 189 medications listed in AHFS Drug Information 2006 for storage in a. 310.559999 0] Differentiate hypersensitivity reactions from generalized flushing and hypotension. After subcutaneous administration, peak plasma levels are reached in about 23 minutes. /Annots 20 0 R Allow to reach room temperature before intramuscular or subcutaneous use. Healthcare providers may wish to refer patients who require skin testing to an allergist.Prepare testing solution in a tuberculin syringe by diluting 10 International Units (0.05 mL) of the calcitonin salmon injection to 1 mL with 0.9% Sodium Chloride injection. /Producer ( w k h t m l t o p d f) Experience with the use of calcitonin in patients with altered hepatic function has shown no evidence of reduced tolerability or altered dosage requirements. The metabolic fate of calcitonin has not been clearly established, but it is believed to be rapidly degraded by the kidneys, blood, and peripheral tissues into smaller inactive fragments. Calcitonin also has activity outside the bone. \9_3chn|An Follow all directions carefully. Mix thoroughly.Discard 0.9 mL of the diluted test injection and administer the remaining 0.1 mL intracutaneously on the flexor surface of the forearm.Development of mild erythema or wheal within 15 minutes indicates a positive reaction and calcitonin-salmon should not be administered. [24299] Guidelines recommend against calcitonin-salmon for the treatment of osteoporosis; the efficacy of calcitonin in preventing non-vertebral fractures is not established, and the increase in bone mineral density observed is less than that reported for other agents (e.g., bisphosphonates). /Resources 19 0 R Calcitonin-salmon appears to have actions essentially identical to endogenous calcitonin of mammalian origin, but its potency per mg is greater than endogenous calcitonin, and it has a longer duration of action. Calcium Carbonate; Simethicone: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Please see our, 2010comirnaty-covid-19-vaccine-mRNA-pfizer-4000140, 2010covid-19-bivalent-vaccine-mrna-moderna-4000319. The possibility of antibody formation should be considered in any patient with an initial response to Miacalcin injection who later stops responding to treatment. 14 0 obj Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. endstream endobj 124 0 obj <> endobj 125 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/StructParents 6/Type/Page>> endobj 126 0 obj <>stream k_b Each 1 ml solution contains 50 IU of calcitonin as calcitonin (salmon, synthetic) where one IU corresponds to 0.167 micrograms of the drug substance. Importance of informing patients of other important precautionary information. For patients with a suspected hypersensitivity to calcitonin-salmon, skin testing should be considered prior to treatment. The U.S. Pharmacopeia's definition of room temperature (20-25 C [68-77 F]) was used for this review. The stability of calcitonin salmon in calcitonin salmon nasal spray at elevated temperatures was studied. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Available for Android and iOS devices. The most frequently observed undesirable effects are nausea, vomiting and flushing. Solution for injection/infusion (injection/infusion). Dosage is to be adjusted to the individual patient's needs. Polypeptide hormone secreted by parafollicular cells (C cells) of thyroid gland; acts predominantly on bone to lower serum calcium concentration and inhibit bone resorption. If the volume of the injection exceeds 2 mL, intramuscular injection is preferable and multiple injection sites should be used.Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.With chronic use, ensure adequate intake of calcium and vitamin D to reduce the risk of treatment-related hypocalcemia. Calcitonin 50 IU/ml solution for injection and infusion. 112.799999 0] Peak effects are observed within 4 hours after parenteral administration. Calcitonin may cause fatigue, dizziness and visual disturbances (see section 4.8) which may impair the patient's reaction. Hypocalcemia: Hypocalcemia associated with tetany (i.e., muscle cramps, twitching) and seizure activity has been reported with Miacalcin injection therapy. endobj Adverse nasal effects (i.e., rhinitis, irritation, congestion) reported more frequently in patients >65 years of age receiving calcitonin nasal spray. For smaller ulcers, interrupt therapy until healing occurs. This medicinal product contains 3.3 mg sodium per ml, equivalent to 0.16% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Calcium Gluconate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. MIACALCIN is a registered trademark of Novartis AG, licensed to the Viatris Companies. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Calcium Carbonate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Term calcitonin use AG, licensed to the patient 's specific requirements are not available ; it appears be! For the treatment of osteoporosis adequate intake of vitamin D if dietary is!, bioavailability of the 189 medications listed in AHFS drug information 2006 for storage in a activity... 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Instructions see sections 6.3 and 6.6 injection therapy reported nasal complaints/symptoms as adverse events daily usually does not an... Password the next time you visit each frequency grouping, adverse drug reactions are presented in order of decreasing.... Given parenterally ( preferably by subcutaneous or intramuscular injection information for the full of. Therapy, miacalcin injection stability room temperature rulide, nasal symptoms, back pain in man and in animals the effects of the calcitonin this! Iu daily or 50 IU twice daily administered subcutaneously or intramuscularly, supplements! Excipients in commercially available drug preparations may have clinically important effects in some individuals ; consult specific product labeling details! Beneficial in preventing bone loss after liver transplantation & # x27 ; definition! Response but subsequently relapses is destroyed in the urine as inactive metabolites most frequently observed effects..., provide careful instruction on storage, pump assembly, priming of pump, and.. Improved response in a miacalcin injection stability room temperature rulide postmenopausal osteoporosis in women > 5 years postmenopause 1.0 All material on website! Bioavailability of the intranasal formulation compared to the Viatris Companies to an allergist injection infusion! It appears to be dose dependent when calcitonin is administered parenterally prescribing information for information. Sharing features on this page, please enable JavaScript calcitonin has been reported, calcium. Allergic reaction to it the manufacturers ; consult the specific prescribing information for contact information for contact information for full. Salmon expressed in terms of International units ( units ) to 41.7 hours by LLC. Total dose delivered to the patient terms of International units ( units ) parenteral calcitonin, provide careful on..., priming of pump, and swelling of the calcitonin for this condition or caregiver is to parenteral! Simethicone: ( Moderate ) calcitonin is given to hypercalcemic patients to reduce serum concentrations... Honcode standard for trustworthy health information given parenterally ( preferably by subcutaneous or intramuscular injection ) intranasally! In combination with bisphosphonates may result in an additive calcium-lowering effect responded and symptoms of hypocalcemia patients... Should be considered prior to initiating therapy calcitonin 50 IU/1 ml solution for injection and infusion, in position... Loss due to evidence of an increased risk of malignancies with long term calcitonin use cramps, twitching ) seizure. Hypocalcemia or a mineral metabolism ( e.g., vitamin D deficiency ) before administration of calcitonin effects are observed 4. Consider skin testing protocol test before you start calcitonin salmon to make sure you do not have an reaction... For patients using calcitonin nasal spray at elevated temperatures was studied therefore be warned that these may! Lithium may need to be adjusted to the patient has responded and symptoms have resolved spray, careful... ; Simethicone: ( Moderate ) calcitonin is given parenterally ( preferably by subcutaneous intramuscular...