Ibandronate Sodium
Generic Name: ibandronate sodium
Brand Names:
Ibandronate Sodium
11 DESCRIPTION Ibandronate sodium is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-( N -methyl- N -pentyl)amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, monohydrate with the molecular formula C 9 H 22 NO 7 P 2 Na•H 2 O and a molecular weight of 359.24. Ibandronate sodium is a white- to off-white powder. It is freely soluble in water and practically insoluble in organic solvents.
Overview
11 DESCRIPTION Ibandronate sodium is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-( N -methyl- N -pentyl)amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, monohydrate with the molecular formula C 9 H 22 NO 7 P 2 Na•H 2 O and a molecular weight of 359.24. Ibandronate sodium is a white- to off-white powder. It is freely soluble in water and practically insoluble in organic solvents.
Uses
1 INDICATIONS AND USAGE Ibandronate sodium injection is a bisphosphonate indicated for the treatment of osteoporosis in postmenopausal women. ( 1.1 ) Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use ( 1.2 ) 1.1 Treatment of Postmenopausal Osteoporosis Ibandronate sodium injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ibandronate sodium injection increases bone mineral density (BMD) and reduces the incidence of vertebral fractures [see Clinical Studies ( 14 )] .
Dosage
2 DOSAGE AND ADMINISTRATION 3 mg every 3 months administered intravenously over a period of 15 to 30 seconds ( 2.2 ) Dosing Instructions: Only administer intravenously by a health care professional. ( 2.1 ) Do not mix with calcium-containing solutions or other intravenously administered drugs. ( 2.1 ) Do not administer more frequently than once every 3 months. ( 2.2 ) Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate 2.1 Important Administration Instructions Ibandronate sodium injection must be administered intravenously only by a health care professional. Care must be taken not to administer intra-arterially or paravenously as this could lead to tissue damage [see Warnings and Precautions ( 5.4 )] .
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse drug reactions are described elsewhere in the labeling: Hypocalcemia and Mineral Metabolism [see Warnings and Precautions ( 5.1 ) ] Anaphylactic Reaction [see Warnings and Precautions ( 5.2 )] Renal Impairment [see Warnings and Precautions ( 5.3 )] Tissue Damage Related to Inappropriate Drug Administration [see Warnings and Precautions ( 5.4 )] Osteonecrosis of the Jaw [see Warnings and Precautions ( 5.5 )] Musculoskeletal [see Warnings and Precautions ( 5.6 )] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions ( 5.7 )] The most frequently reported adverse reactions (>5%) are arthralgia, back pain, and abdominal pain.
Interactions
7 DRUG INTERACTIONS 7.1 Melphalan/Prednisolone Intravenous ibandronate (6 mg) did not interact with intravenous melphalan (10 mg/m 2 ) or oral prednisolone (60 mg/m 2 ). [See Clinical Pharmacology ( 12.3 )] 7.2 Tamoxifen There was no interaction between oral 30 mg tamoxifen and intravenous 2 mg ibandronate. [See Clinical Pharmacology ( 12.3 )] 7.3 Bone Imaging Agents Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with ibandronate sodium injection have not been performed.
Warnings
5 WARNINGS AND PRECAUTIONS Hypocalcemia can worsen. Correct hypocalcemia prior to use. Adequately supplement patients with calcium and vitamin D ( 5.1 ) Anaphylaxis , including fatal events, has been reported. ( 5.2 ) Renal Toxicity may be greater in patients with underlying renal impairment. Do not administer ibandronate sodium injection to patients with severe renal impairment (creatinine clearance less than 30 mL/min). Monitor serum creatinine prior to each dose. ( 5.3 ) Tissue Damage with Inappropriate Drug Administration can occur. Do not administer ibandronate sodium injection intra-arterially or paravenously. ( 5.4 ) Osteonecrosis of the jaw (ONJ ) has been reported. ( 5.5 ) Severe Bone, Joint, and/or Muscle Pain may occur, consider discontinuing use if symptoms occur. 4 CONTRAINDICATIONS Ibandronate sodium injection is contraindicated in patients with the following conditions: Hypocalcemia [see Warnings and Precautions ( 5.1 )] Known hypersensitivity to ibandronate sodium injection or to any of its excipients. Cases of anaphylaxis, including fatal events, have been reported.
Pregnancy
8.1 Pregnancy Risk Summary Ibandronate sodium injection is not indicated for use in women of reproductive potential. There are no data with ibandronate sodium injection use in pregnant women to inform any drug-associated risks. In reproductive toxicity studies in the rat, ibandronate sodium injection caused obstruction of labor, with maternal periparturient mortality, pup loss and reduced pup weight at greater than or equal to 2 times human exposure at the recommended human intravenous dose of 3 mg. Abnormal pup odontogeny was observed at greater than or equal to 18 times human exposure.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Ibandronate sodium injection is available as follows: NDC 62756-218-40 1 mg/mL, 3 mL single-dose vial, carton of 1 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
Frequently Asked Questions
What is Ibandronate Sodium used for?▼
1 INDICATIONS AND USAGE Ibandronate sodium injection is a bisphosphonate indicated for the treatment of osteoporosis in postmenopausal women. ( 1.1 ) Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use ( 1.2 ) 1.1 Treatment of Postmenopausal Osteoporosis Ibandronate sodium injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ibandronate sodium injection increases bone mineral density (BMD) and reduces the incidence of vertebral fractures [see Clinical Studies ( 14 )] .
What are the side effects of Ibandronate Sodium?▼
6 ADVERSE REACTIONS The following clinically significant adverse drug reactions are described elsewhere in the labeling: Hypocalcemia and Mineral Metabolism [see Warnings and Precautions ( 5.1 ) ] Anaphylactic Reaction [see Warnings and Precautions ( 5.2 )] Renal Impairment [see Warnings and Precautions ( 5.3 )] Tissue Damage Related to Inappropriate Drug Administration [see Warnings and Precautions ( 5.4 )] Osteonecrosis of the Jaw [see Warnings and Precautions ( 5.5 )] Musculoskeletal [see Warnings and Precautions ( 5.6 )] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions ( 5.7 )] The most frequently reported adverse reactions (>5%) are arthralgia, back pain, and abdominal pain.
Can I take Ibandronate Sodium during pregnancy?▼
8.1 Pregnancy Risk Summary Ibandronate sodium injection is not indicated for use in women of reproductive potential. There are no data with ibandronate sodium injection use in pregnant women to inform any drug-associated risks. In reproductive toxicity studies in the rat, ibandronate sodium injection caused obstruction of labor, with maternal periparturient mortality, pup loss and reduced pup weight at greater than or equal to 2 times human exposure at the recommended human intravenous dose of 3 mg. Abnormal pup odontogeny was observed at greater than or equal to 18 times human exposure.
What are the important warnings for Ibandronate Sodium?▼
5 WARNINGS AND PRECAUTIONS Hypocalcemia can worsen. Correct hypocalcemia prior to use. Adequately supplement patients with calcium and vitamin D ( 5.1 ) Anaphylaxis , including fatal events, has been reported. ( 5.2 ) Renal Toxicity may be greater in patients with underlying renal impairment. Do not administer ibandronate sodium injection to patients with severe renal impairment (creatinine clearance less than 30 mL/min). Monitor serum creatinine prior to each dose. ( 5.3 ) Tissue Damage with Inappropriate Drug Administration can occur. Do not administer ibandronate sodium injection intra-arterially or paravenously. ( 5.4 ) Osteonecrosis of the jaw (ONJ ) has been reported. ( 5.5 ) Severe Bone, Joint, and/or Muscle Pain may occur, consider discontinuing use if symptoms occur. 4 CONTRAINDICATIONS Ibandronate sodium injection is contraindicated in patients with the following conditions: Hypocalcemia [see Warnings and Precautions ( 5.1 )] Known hypersensitivity to ibandronate sodium injection or to any of its excipients. Cases of anaphylaxis, including fatal events, have been reported.
Related Medications
Orfroglipron
orfroglipron
Dosage form: POWDER. Active ingredients: ORFORGLIPRON (1 g/g). Category: BULK INGREDIENT.
Etidronate Disodium
etidronate disodium
Manufactured by MGI PHARMA INC. Dosage form: INJECTABLE. Route: INJECTION. Active ingredients: ETIDRONATE DISODIUM (50MG/ML). Application: NDA019545.
Hydrocortisone, Clioquinol, Zinc Oxide
hydrocortisone, clioquinol, zinc oxide
Standardized Chemical Allergen [EPC]
Purpose Pruritis ani (anal itching) cream
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.