Boniva

• Generic Name: ibandronate sodium
• Brand Name: Boniva

Boniva (Ibandronate Sodium) side effects drug center

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PROFESSIONAL

CONSUMER

SIDE EFFECTS

• Overview
• Professional Information

 

Boniva Side Effects Center

What Is Boniva?

Boniva (ibandronate) is a bisphosphonate drug that alters the cycle of bone formation and breakdown in the body used to treat or prevent osteoporosis in women after menopause. Boniva slows bone loss while increasing bone mass, which may prevent bone fractures.

What Are Side Effects of Boniva?

Side effects of Boniva include:

• back pain,
• headache,
• redness or swelling of your eyes,
• diarrhea,
• flu-like symptoms,
• nausea or stomach upset,
• pain in your arms or legs,
• redness or swelling where Boniva was injected,
• weakness,
• allergic reaction,
• indigestion,
• vomiting,
• joint pain,
• dizziness,
• spinning sensation (vertigo),
• upper respiratory infection,
• pneumonia, or
• urinary tract infection.

Dosage for Boniva

The dose of Boniva is one 150 mg tablet taken once monthly on the same date each month.

What Drugs, Substances, or Supplements Interact with Boniva?

Boniva may interact with products containing calcium, aluminum, magnesium, or iron (such as antacids, supplements or vitamins); aspirin or NSAIDs. Tell your doctor all medications and supplements you use.

Boniva During Pregnancy and Breastfeeding

There are no adequate and well-controlled studies of this drug in pregnant women. It is not known whether ibandronate is excreted in human milk. Boniva is typically given to women after menopause.

Additional Information

Our Boniva Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Boniva Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ibandronate and call your doctor at once if you have:

• chest pain, new or worsening heartburn;
• difficulty or pain when swallowing;
• pain or burning under the ribs or in the back;
• severe heartburn, burning pain in your upper stomach, or coughing up blood;
• new or unusual pain in your thigh or hip;
• jaw pain, numbness, or swelling;
• severe joint, bone, or muscle pain; or
• low calcium levels--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common side effects may include:

• heartburn, stomach pain, diarrhea;
• back pain, bone pain, muscle or joint pain;
• pain in your arms or legs;
• headache; or
• fever, chills, tiredness, flu-like symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Boniva (Ibandronate Sodium)

 

Boniva Professional Information

SIDE EFFECTS

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.

Treatment And Prevention Of Postmenopausal Osteoporosis

Daily Dosing

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 group. The percentage of patients who withdrew from treatment due to adverse reactions was approximately 17% in both the BONIVA 2.5 mg daily group and the placebo group. Table 1 lists adverse reactions from the treatment and prevention studies reported in greater than or equal to 2% of patients and more frequently in patients treated daily with BONIVA than patients treated with placebo.

Table 1 Adverse Reactions Occurring at an Incidence Greater Than or Equal to 2% and in More Patients Treated with BONIVA Than in Patients Treated with Placebo Daily in the Osteoporosis Treatment and Prevention Studies

Body System	Placebo % (n=1134)	BONIVA 2.5 mg % (n=1140)
Body as a Whole
Back Pain	12	14
Pain in Extremity	6	8
Asthenia	2	4
Allergic Reaction	2	3
Digestive System
Dyspepsia	10	12
Diarrhea	5	7
Tooth Disorder	2	4
Vomiting	2	3
Gastritis	2	2
Musculoskeletal System
Myalgia	5	6
Joint Disorder	3	4
Arthritis	3	3
Nervous System
Headache	6	7
Dizziness	3	4
Vertigo	3	3
Respiratory System
Upper Respiratory Infection	33	34
Bronchitis	7	10
Pneumonia	4	6
Pharyngitis	2	3
Urogenital System
Urinary Tract Infection	4	6

Gastrointestinal Adverse Reactions

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%).

Musculoskeletal Adverse Reactions

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%).

Ocular Adverse Events

Reports in the medical literature indicate that bisphosphonates may be associated with ocular inflammation such as iritis and scleritis. In some cases, these events did not resolve until the bisphosphonate was discontinued. There were no reports of ocular inflammation in studies with BONIVA 2.5 mg daily.

Monthly Dosing

The safety of BONIVA 150 mg once monthly in the treatment of postmenopausal osteoporosis was assessed in a two year trial which enrolled 1583 patients aged 54 – 81 years, with 395 patients exposed to BONIVA 2.5 mg daily and 396 exposed to BONIVA 150 mg monthly. Patients with active or significant pre-existing gastrointestinal disease were excluded from this trial. Patients with dyspepsia or concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors and H2 antagonists were included in this study. All patients received 500 mg calcium plus 400 international units vitamin D supplementation daily.

After one year, the incidence of all-cause mortality was 0.3% in both the BONIVA 2.5 mg daily group and the BONIVA 150 mg monthly group. The incidence of serious adverse events was 5% in the BONIVA 2.5 mg daily group and 7% in the BONIVA 150 mg monthly group. The percentage of patients who withdrew from treatment due to adverse events was 9% in the BONIVA 2.5 mg daily group and 8% in the BONIVA 150 mg monthly group. Table 2 lists the adverse events reported in greater than or equal to 2% of patients.

Table 2 Adverse Events with an Incidence of at Least 2% in Patients Treated with BONIVA 2.5 mg Daily or 150 mg Once-Monthly for Treatment of Postmenopausal Osteoporosis

Body System/Adverse Event	BONIVA 2.5 mg Daily % (n=395)	BONIVA 150 mg Monthly % (n=396)
Vascular Disorders
Hypertension	7.3	6.3
Gastrointestinal Disorders
Dyspepsia	7.1	5.6
Nausea	4.8	5.1
Diarrhea	4.1	5.1
Constipation	2.5	4.0
Abdominal Paina	5.3	7.8
Musculoskeletal and Connective Tissue Disorders
Arthralgia	3.5	5.6
Back Pain	4.3	4.5
Pain in Extremity	1.3	4.0
Localized Osteoarthritis	1.3	3.0
Myalgia	0.8	2.0
Muscle Cramp	2.0	1.8
Infections and Infestations
Influenza	3.8	4.0
Nasopharyngitis	4.3	3.5
Bronchitis	3.5	2.5
Urinary Tract Infection	1.8	2.3
Upper Respiratory Tract Infection	2.0	2.0
Nervous System Disorders
Headache	4.1	3.3
Dizziness	1.0	2.3
General Disorders and Administration Site Conditions
Influenza-like Illnessb	0.8	3.3
Skin and Subcutaneous Tissue Disorders
Rashc	1.3	2.3
Psychiatric Disorders
Insomnia	0.8	2.0
a Combination of abdominal pain and abdominal pain upper b Combination of influenza-like illness and acute phase reaction c Combination of rash pruritic, rash macular, rash papular, rash generalized, rash erythematous, dermatitis, dermatitis allergic, dermatitis medicamentosa, erythema and exanthema

Gastrointestinal Adverse Events

The incidence of adverse events in the BONIVA 2.5 mg daily and BONIVA 150 mg monthly groups were: dyspepsia (7% vs. 6%), diarrhea (4% vs. 5%), and abdominal pain (5% vs. 8%).

Musculoskeletal Adverse Events

The incidence of adverse events in the BONIVA 2.5 mg daily and BONIVA 150 mg monthly groups were: back pain (4% vs. 5%), arthralgia (4% vs. 6%) and myalgia (1% vs. 2%).

Acute Phase Reactions

Symptoms consistent with acute phase reactions have been reported with bisphosphonate use. Over the two years of the study, the overall incidence of acute phase reaction symptoms was 3% in the BONIVA 2.5 mg daily group and 9% in the BONIVA 150 mg monthly group. These incidence rates are based on the reporting of any of 33 acute-phase reaction like symptoms within 3 days of the monthly dosing and lasting 7 days or less. Influenza like illness was reported in no patients in the BONIVA 2.5 mg daily group and 2% in the BONIVA 150 mg monthly group.

Ocular Adverse Events

Two patients who received BONIVA 150 mg once-monthly experienced ocular inflammation, one was a case of uveitis and the other scleritis.

One hundred sixty (160) postmenopausal women without osteoporosis participated in a 1-year, double-blind, placebo-controlled study of BONIVA 150 mg once-monthly for prevention of bone loss. Seventy-seven subjects received BONIVA and 83 subjects received placebo. The overall pattern of adverse events was similar to that previously observed.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of BONIVA. 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 anaphylactic reaction/shock with fatalities, angioedema, bronchospasm, asthma exacerbations, rash, Stevens-Johnson syndrome, erythema multiforme, and dermatitis bullous have been reported (see CONTRAINDICATIONS).

Hypocalcemia

Hypocalcemia has been reported in patients treated with BONIVA (see WARNINGS AND PRECAUTIONS).

Musculoskeletal Pain

Bone, joint, or muscle pain (musculoskeletal pain), described as severe or incapacitating, has been reported (see WARNINGS AND PRECAUTIONS).

Jaw Osteonecrosis

Osteonecrosis of the jaw and other oro-facial sites, including the external auditory canal, have been reported in patients treated with BONIVA (see WARNINGS AND PRECAUTIONS).

Atypical Femoral Shaft Fracture

Atypical, low-energy, or low-trauma fractures of the femoral shaft (see WARNINGS AND PRECAUTIONS).

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

&Copy; Boniva Patient Information is supplied by Cerner Multum, Inc. and Boniva Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.