i-BAN-dro-nate

• Treatment/prevention of postmenopausal osteoporosis.

• Inhibits resorption of bone by inhibiting osteoclast activity.

• Reversal/prevention of progression of osteoporosis with decreased fractures.

Absorption: 0.6% absorbed following oral administration (significantly ↓ by food).

Distribution: Rapidly binds to bone.

Protein Binding: 90.9–99.5%.

Metabolism/Excretion: 50–60% excreted in urine; unabsorbed drug is eliminated in feces.

Half-life: PO — 10–60 hr; IV — 4.6–25.5 hr.

Contraindicated in:

• Hypersensitivity
• Abnormalities of the esophagus which delay esophageal emptying (i.e. strictures, achalasia)
• Uncorrected hypocalcemia
• Inability to stand/sit upright for at least 60 min
• CCr <30 mL/min.

Use Cautiously in:

• History of upper GI disorders
• Concurrent use of NSAIDs or aspirin
• Invasive dental procedures, cancer, receiving chemotherapy, corticosteroids, or angiogenesis inhibitors, poor oral hygiene, periodontal disease, dental disease, anemia, coagulopathy, infection, or poorly-fitting dentures (may ↑ risk of jaw osteonecrosis)
• OB: Use only if potential benefit outweighs risks to mother and fetus
• Lactation: Lactation
• Pedi: Children <18 yr (safety not established)
• Geri: Consider age related ↓ in body mass, renal and hepatic function, concurrent disease states, and drug therapy.

GI: diarrhea, dyspepsia, dysphagia, esophageal cancer, esophagitis, esophageal/gastric ulcer.

MS: musculoskeletal pain, pain in arms/legs, femur fractures, osteonecrosis (primarily of jaw).

Derm: ERYTHEMA MULTIFORME, STEVENS-JOHNSON SYNDROME.

Resp: asthma exacerbation.

Misc: ANAPHYLAXIS, injection site reactions.

Drug-Drug:

• Calcium-, aluminum-, magnesium-, and iron-containing products, including antacids↓ absorption (ibandronate should be taken 60 min before).
• Concurrent use of NSAIDs including aspirin, may ↑ risk of gastric irritation.

Drug-Food:

• Milk and other foods ↓ absorption.

• PO (Adults): 150 mg once monthly.
• IV (Adults): 3 mg every 3 mo.

• PO: Administer first thing in the morning with 6–8 oz plain water 30 min before other medications, beverages, or food. Tablet should be swallowed whole; do not break, crush, or chew.
  • Once-monthly tablet should be administered on the same date each mo.

IV Administration:

• IV: Administer using prefilled syringe. Do not administer solution that is discolored or contains particulate matter. Administer IV only; other routes may cause tissue damage.
• Rate: Administer as a 15–30 sec bolus.
• Y-Site Incompatibility: Do not administer with calcium-containing solutions or other IV drugs.

Boniva

Therapeutic Classification: bone resorption inhibitors

Pharmacologic Classification: biphosphonates

(Generic available)

• Tablets: 150 mg;
• Injection: 3 mg/3 mL in prefilled single-use syringe;

• Osteoporosis: Assess patients for low bone mass before and periodically during therapy.
• IV: Monitor for signs and symptoms of anaphylactic reactions (swelling of face, lips, mouth or tongue; trouble breathing; wheezing; severe itching; skin rash, redness or swelling; dizziness or fainting; fast heartbeat or pounding in chest; sweating) during therapy. Discontinue injection immediately and begin supportive treatment if symptoms occur.
• Perform a routine oral exam prior to initiation of therapy. Dental exam with appropriate preventative dentistry should be considered prior to therapy. Patients with history of tooth extraction, poor oral hygiene, gingival infections, diabetes, or use of a dental appliance or those taking immunosuppressive therapy, angiogenesis inhibitors, or systemic corticosteroids are at greater risk for osteonecrosis of the jaw.

• Assess serum calcium before and periodically during therapy. Hypocalcemia and vitamin D deficiency should be treated before initiating ibandronate therapy.
  • May cause ↓ total alkaline phosphatase levels.
  • May cause hypercholesterolemia.

• Risk for injury (Indications).

• Advise patient to eat a balanced diet and consult health care professional about the need for supplemental calcium and vitamin D. Wait at least 60 min after administration before taking supplemental calcium and vitamin D.
  • Encourage patient to participate in regular exercise and to modify behaviors that increase the risk of osteoporosis (stop smoking, reduce alcohol consumption).
  • Inform patient that severe musculoskeletal pain may occur within days, mo, or yr after starting ibandronate. Symptoms may resolve completely after discontinuation or slow or incomplete resolution may occur. Notify health care professional if severe pain occurs.
  • Advise patient to notify health care professional if rash or signs and symptoms of osteonecrosis of the jaw (pain, numbness, swelling of or drainage from the jaw, mouth, or teeth) occur.
  • Instruct patient to notify health care professional if swallowing difficulties, chest pain, new or worsening heartburn, or trouble or pain when swallowing occurs; may be signs of problems of the esophagus.
  • Advise patient to inform health care professional of ibandronate therapy prior to dental surgery.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.
• PO: Instruct patient on the importance of taking as directed, first thing in the morning, 60 min before other medications, beverages, or food. Ibandronate should be taken with 6–8 oz plain water (mineral water, orange juice, coffee, and other beverages decrease absorption). Do not chew or suck on tablet. If a dose is missed, skip dose and resume the next morning; do not double doses or take later in the day. If a once-monthly dose is missed and the next scheduled dose is >7 days away, take in the morning following the date it is remembered. Resume original schedule the following mo. If the next dose is <7 days away, omit dose and take next scheduled dose. Do not discontinue without consulting health care professional.
  • Caution patient to remain upright for 60 min following dose to facilitate passage to stomach and minimize risk of esophageal irritation. Advise patient to stop taking ibandronate and contact health care professional if symptoms of esophageal irritation (new or worsening dysphagia, pain on swallowing, retrosternal pain, or heartburn) occur.
• IV: Advise patient that IV doses should not be administered sooner that every 3 mo. If a dose is missed, have health care professional administer as soon as possible; next injection should be scheduled 3 mo from last injection.

• Prevention of or decrease in the progression of osteoporosis in postmenopausal women. Discontinuation after 3–5 yr should be considered for women with low risk for fractures.

NDC Code^*

• 0004- Genentech, Inc.
  • 0004-0186- Boniva
    • 0004-0186-83- 1 BLISTER PACK in 1 BOX (0004-0186-83) > 3 TABLET, FILM COATED in 1 BLISTER PACK

• 0004- Genentech, Inc.
  • 0004-0191- Boniva
    • 0004-0191-09- 1 SYRINGE, GLASS in 1 CARTON (0004-0191-09) > 3 mL in 1 SYRINGE, GLASS

• 23155- Heritage Pharmaceuticals Inc.
  • 23155-162- Ibandronate sodium
    • 23155-162-31- 3 mL in 1 VIAL, GLASS (23155-162-31)

• 25021- Sagent Pharmaceuticals
  • 25021-827- ibandronate sodium
    • 25021-827-61- 1 SYRINGE in 1 CARTON (25021-827-61) > 3 mL in 1 SYRINGE

• 33342- Macleods Pharmaceuticals Limited
  • 33342-150- IBANDRONATE SODIUM
    • 33342-150-53- 3 CARTON in 1 BOX (33342-150-53) > 1 BLISTER PACK in 1 CARTON (33342-150-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK

• 47781- Alvogen Inc.
  • 47781-103- IBANDRONATE SODIUM
    • 47781-103-21- 1 BLISTER PACK in 1 CARTON (47781-103-21) > 3 TABLET in 1 BLISTER PACK

• 47781- Alvogen Inc.
  • 47781-103- IBANDRONATE SODIUM
    • 47781-103-33- 3 BLISTER PACK in 1 BOX (47781-103-33) > 1 TABLET in 1 BLISTER PACK (47781-103-07)

• 55111- Dr. Reddy's Laboratories Limited
  • 55111-575- Ibandronate sodium
    • 55111-575-03- 3 BLISTER PACK in 1 CARTON (55111-575-03) > 1 TABLET in 1 BLISTER PACK (55111-575-11)

• 55111- Dr. Reddy's Laboratories Limited
  • 55111-575- Ibandronate sodium
    • 55111-575-43- 1 BLISTER PACK in 1 CARTON (55111-575-43) > 3 TABLET in 1 BLISTER PACK (55111-575-13)

• 55150- AuroMedics Pharma LLC
  • 55150-191- Ibandronate Sodium
    • 55150-191-83- 1 SYRINGE, GLASS in 1 CARTON (55150-191-83) > 3 mL in 1 SYRINGE, GLASS

• 60429- Golden State Medical Supply, Inc.
  • 60429-643- IBANDRONATE SODIUM
    • 60429-643-73- 3 BLISTER PACK in 1 PACKAGE (60429-643-73) > 1 TABLET, FILM COATED in 1 BLISTER PACK

• 60505- Apotex Corp
  • 60505-2795- IBANDRONATE SODIUM
    • 60505-2795-0- 3 BLISTER PACK in 1 PACKAGE (60505-2795-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK

• 60505- Apotex Corp.
  • 60505-6097- Ibandronate Sodium
    • 60505-6097-0- 1 SYRINGE, GLASS in 1 CARTON (60505-6097-0) > 3 mL in 1 SYRINGE, GLASS

• 62756- Sun Pharmaceutical Industries, Inc.
  • 62756-218- IBANDRONATE SODIUM
    • 62756-218-40- 1 VIAL, SINGLE-DOSE in 1 CARTON (62756-218-40) > 3 mL in 1 VIAL, SINGLE-DOSE

• 65862- Aurobindo Pharma Limited
  • 65862-237- Ibandronate Sodium
    • 65862-237-03- 1 BLISTER PACK in 1 CARTON (65862-237-03) > 3 TABLET, FILM COATED in 1 BLISTER PACK

• 67457- Mylan Institutional LLC
  • 67457-524- ibandronate sodium
    • 67457-524-33- 1 SYRINGE, GLASS in 1 CARTON (67457-524-33) > 3 mL in 1 SYRINGE, GLASS