Boniva Injection

• Boniva^® Injection

Do not take an ibandronate tablet if you cannot sit upright or stand for at least one full hour. Ibandronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 60 minutes after taking this medication.

Take the ibandronate tablet first thing in the morning, at least 1 hour (60 minutes) before you eat or drink anything or take any other medicine.

Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an ibandronate tablet.

For at least the first 60 minutes after taking an ibandronate tablet, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.

Some people using medicines similar to ibandronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using ibandronate. You may need to stop using the medicine for a short time.

Talk with your doctor about the risks and benefits of using this medication.

Adverse reactions that appear in other sections of the labeling include:

• Hypocalcemia and Mineral Metabolism [see WARNINGS AND PRECAUTIONS]
• Anaphylactic Reaction [see WARNINGS AND PRECAUTIONS]
• Renal Impairment [see WARNINGS AND PRECAUTIONS]
• Tissue Damage Related to Inappropriate Drug Administration [see WARNINGS AND PRECAUTIONS]
• Osteonecrosis of the Jaw [see WARNINGS AND PRECAUTIONS]
• Musculoskeletal Pain [see WARNINGS AND PRECAUTIONS]
• Atypical Subtrochanteric and Diaphyseal Femoral Fractures [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a 1-year, double-blind, multicenter study comparing BONIVA Injection administered intravenously as 3 mg every 3 months to BONIVA 2.5 mg daily oral tablet in women with postmenopausal osteoporosis, the overall safety and tolerability profiles of the two dosing regimens were similar. The incidence of serious adverse reactions was 8.0% in the BONIVA 2.5 mg daily group and 7.5% in the BONIVA Injection 3 mg once every 3 months group. The percentage of patients who withdrew from treatment due to adverse reactions was approximately 6.7% in the BONIVA 2.5 mg daily group and 8.5% in the BONIVA Injection 3 mg every 3 months group. Table 1 lists the adverse reactions reported in greater than 2% of patients.

Table 1 : Adverse Reactions With an Incidence of at Least 2% in Patients Treated with BONIVA Injection (3 mg once every 3 months) or BONIVA Daily Oral Tablet (2.5 mg)

Symptoms consistent with acute phase reaction (APR) have been reported with intravenous bisphosphonate use. The overall incidence of patients with APR-like events was higher in the intravenous treatment group (4% in the BONIVA 2.5 mg daily oral tablet group vs. 10% in the BONIVA Injection 3 mg once every 3 months group). These incidence rates are based upon reporting of any of 33 potential APR-like symptoms within 3 days of an intravenous dose and lasting 7 days or less. In most cases, no specific treatment was required and the symptoms subsided within 24 to 48 hours.

Local reactions at the injection site, such as redness or swelling, were observed at a higher incidence in patients treated with BONIVA Injection 3 mg every 3 months (1.7%; 8/469) than in patients treated with placebo injections (0.2%; 1/465). In most cases, the reaction was of mild to moderate severity.

The safety of BONIVA 2.5 mg once daily in the treatment and prevention of postmenopausal osteoporosis was assessed in 3577 patients aged 41 - 82 years. The duration of the trials was 2 to 3 years, with 1134 patients exposed to placebo and 1140 exposed to BONIVA 2.5 mg. Patients with pre-existing gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors and H2 antagonists were included in these clinical trials. All patients received 500 mg calcium plus 400 international units vitamin D supplementation daily.

The incidence of all-cause mortality was 1% in the placebo group and 1.2% in the BONIVA 2.5 mg daily group. The incidence of serious adverse reactions was 20% in the placebo group and 23% in the BONIVA 2.5 mg daily oral tablet group. The percentage of patients who withdrew from treatment due to adverse reactions was approximately 17% in both the placebo group and the BONIVA 2.5 mg daily oral tablet group. Table 2 lists adverse reactions from the Treatment and Prevention Studies reported in greater than or equal to 2% of patients and in more patients treated with BONIVA 2.5 mg daily oral tablet than patients treated with placebo.

Table 2 : Adverse Reactions Occurring at an Incidence greater than or equal to 2% and in More Patients Treated with BONIVA 2.5 mg Daily Oral Tablet than in Patients Treated with Placebo in the Osteoporosis Treatment and Prevention Studies

The incidence of selected gastrointestinal adverse reactions in the placebo and BONIVA 2.5 mg daily groups were: dyspepsia (10% vs. 12%), diarrhea (5% vs. 7%), and abdominal pain (5% vs. 6%).

The incidence of selected musculoskeletal adverse reactions in the placebo and BONIVA 2.5 mg daily groups were: back pain (12% vs. 14%), arthralgia (14% vs. 14%) and myalgia (5% vs. 6%).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of BONIVA Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity: Allergic reactions including anaphylaxis with fatalities, angioedema, asthma exacerbation, bronchospasm, rash, Stevens-Johnson syndrome, erythema multiforme, and dermatitis bullous [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].

Hypocalcemia: Hypocalcemia [see WARNINGS AND PRECAUTIONS].

Renal Toxicity: Acute renal failure [see WARNINGS AND PRECAUTIONS].

Osteonecrosis of the Jaw: Osteonecrosis of the jaw [see WARNINGS AND PRECAUTIONS].

Musculoskeletal Pain: Bone, joint, or muscle pain (musculoskeletal pain), described as severe or incapacitating [see WARNINGS AND PRECAUTIONS].

Atypical Femoral Shaft Fracture: Atypical, low-energy, or low-trauma fractures of the femoral shaft [see WARNINGS AND PRECAUTIONS].

Eye Inflammation: Iritis and uveitis. In some cases with other bisphosphonates, these events did not resolve until the bisphosphonate was discontinued.

Read the entire FDA prescribing information for Boniva Injection (Ibandronate Sodium Injection)