Boniva

Boniva is a prescription medication used to treat or prevent the thinning of bones, known medically as osteoporosis, in postmenopausal women. Boniva belongs to a group of drugs called bisphosphonates, which slow the breakdown of bone.

This medication comes in tablet form. It is taken once a month, on an empty stomach with a glass of water. 

This medication is also available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects include back pain, heartburn, and abdominal (stomach area) pain.

Oral:

• Boniva is a prescription medicine used to treat or prevent osteoporosis (thinning of bones and increased risk of bones breaking). It is used in women who have gone through menopause (the end of menstrual periods).
• This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

Injectable:

• Boniva is a prescription medicine used to treat or prevent osteoporosis (thinning of bones and increased risk of bones breaking).
• This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

• Genentech, Inc.

Oral/Injectable:

Boniva may cause serious side effects. See "Boniva Precautions".

Common side effects include:

• Back pain
• Heartburn
• Stomach area (abdominal) pain
• Pain in your arms and legs
• Diarrhea
• Headache
• Muscle pain
• Flu-like symptoms

You may get allergic reactions, such as hives or, in rare cases, swelling of your face, lips, tongue or throat.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Boniva. For more information, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take or plan to take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• aspirin
• ibuprofen (Motrin, Advil)
• other NSAIDS (non-steroidal anti-inflammatory drugs) 
• antacids, supplements, or medicines containing aluminum, calcium, or magnesium

This is not a complete list of Boniva drug interactions. Ask your doctor or pharmacist for more information.

Oral/Injectable:

Boniva can cause serious side effects including:

1. Esophagus problems
2. Low calcium levels in your blood (hypocalcemia)
3. Bone, joint or muscle pain
4. Severe jaw bone problems (osteonecrosis)
5. Unusual thigh bone fractures

1.  Esophagus problems. 

Some people who take Boniva may develop problems in the esophagus (the tube that connects the mouth and the stomach). These problems include irritation, inflammation, or ulcers of the esophagus which may sometimes bleed.

• It is important that you take Boniva exactly as prescribed to help lower your chance of getting esophagus problems.
• Stop taking Boniva and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when you swallow.

2.  Low calcium levels in your blood (hypocalcemia). 

Boniva may lower the calcium levels in your blood. If you have low blood calcium before you start taking Boniva, it may get worse during treatment. Your low blood calcium must be treated before you take Boniva. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:

• Spasms, twitches, or cramps in your muscles
• Numbness or tingling in your fingers, toes, or around your mouth

Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take Boniva. Take calcium and vitamin D as your doctor tells you to.

3.  Bone, joint, or muscle pain. 

Some people who take Boniva develop severe bone, joint, or muscle pain.

4.  Severe jaw bone problems (osteonecrosis). 

Severe jaw bone problems may happen when you take Boniva. Your doctor may examine your mouth before you start Boniva. Your doctor may tell you to see your dentist before you start Boniva. It is important for you to practice good mouth care during treatment with Boniva.

5.  Unusual thigh bone fractures. 

Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh.

Call your doctor right away if you have any of these side effects.

Do not take Boniva if you:

• Have certain problems with your esophagus, the tube that connects your mouth with your stomach
• Cannot stand or sit upright for at least 60 minutes
• Have low levels of calcium in your blood
• Are allergic to Boniva or any of its ingredients

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Boniva there are no specific foods that you must exclude from your diet when receiving Boniva. However, it is important that you take Boniva tablets on an empty stomach, first thing in the morning before you eat or drink anything other than plain water. Food or beverages can prevent it from being absorbed into the body.

Before receiving Boniva tell your doctor about all of your medical conditions including if you:

• Have problems with swallowing
• Have stomach or digestive problems
• Have low blood calcium
• Plan to have dental surgery or teeth removed
• Have kidney problems
• Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)

Tell your doctor if you are pregnant or breastfeeding.

Tell your doctor and dentist about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Boniva falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is not known if Boniva crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Boniva.

Take Boniva exactly as your doctor tells you.

Oral:

• Boniva works only if taken on an empty stomach.
• Take 1 Boniva tablet after you get up for the day and before taking your first food, drink, or other medicine.
• Take Boniva while you are sitting or standing.
• Do not chew or suck on a tablet of Boniva.
• Swallow Boniva tablet with a full glass (6-8 oz) of plain water only.
• Do not take Boniva with mineral water, coffee, tea, soda, or juice.
• After swallowing Boniva tablet, wait at least 60 minutes before:
  • lying down. You may sit, stand or walk, and do normal activities like reading.
  • you take your first food or drink except for plain water
  • you take other medicines, including antacids, calcium, and other supplements and vitamins
• Do not lie down for at least 60 minutes after you take Boniva and do not eat your first food of the day for at least 60 minutes after you take Boniva.
• If you miss a dose of Boniva, do not take it later in the day. Call your doctor for instructions.

Injectable:

• This medication is also available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Take Boniva exactly as your doctor has prescribed it. Carefully follow the directions on your prescription label.

Oral:

• The Boniva 2.5 mg tablet is taken once daily.
• The Boniva 150 mg tablet should be taken once on the same date each month. 
• The recommended dose of Boniva injection for postmenopausal osteoporosis is 3 mg every 3 months.

Injectable:

• This medication is available in an injectable form to be dosed by a healthcare professional.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Boniva at room temperature.
• Keep Boniva and all medicines out of the reach of children.