Ibandronate (Oral)

Ibandronate (Boniva) is a bone health tablet that is used to treat and prevent a condition known as osteoporosis in post-menopausal women.

Overview

The rate of bone loss increases in women, especially after menopause. This leads to a condition called osteoporosis. It causes the bones to become thin and brittle, and easy to fracture. Even a simple slip-and-fall accident can cause major bone breakage in these patients.

Bones are constantly forming and breaking down in the body. Ibandronate enhances bone health by changing the way bones form and break down. The result is a decrease in bone loss, an increase in bone mass, and a reduced risk of bone breakage.

The tablet is shown to be more effective during treatment when patients take sufficient calcium and vitamin D in their diet.

Ibandronate is supplied in the form of a tablet and is sold in the US under the brand name, Boniva. Patients must have a doctor's prescription to get this medicine. It may be used to treat other medical conditions not discussed in this guide.

Condition treated:

  • Post-menopausal Osteoporosis

Type Of Medicine

  • Bisphosphonate

Side Effects

Prescription medicines, such as Ibandronate, generally cause various side effects. Some of them are necessary and expected as the medicine works in the body.

Ibandronate may cause some side effects that are unwanted and may or may not require medical attention.

Severe adverse reactions

Irritation or ulcers in the esophagus and jaw problems (osteonecrosis) are two of the serious problems that may develop from using Ibandronate.

Irritation or ulcers in the esophagus tend to happen when patients continue taking the medicine after their esophagus becomes irritated. Not drinking enough water when taking the drug or lying down to soon after (less than 1 hour) may also cause these problems.

Patients with esophagus abnormalities are more likely to experience these problems.

Other patients may develop jaw problems which typically happens due to infection or slow healing after a tooth is extracted.

The following other general side effects may occur and require immediate medical attention. Call your doctor right away if you notice any of these:

More commonly occur

  • Fever or chills
  • Difficulty breathing
  • Pain in the lower back or side
  • Bladder pain
  • Urine that appears cloudy or bloody
  • Chest pain
  • Shortness of breath
  • Cough (that brings up mucus)
  • Pain, burning or difficulty when urinating
  • Soreness throat
  • Increased urge to urinate
  • Nervousness
  • Heartbeat that is fast or slow
  • Sneezing
  • Tightness in the chest
  • Pounding sensation in the ears

Less commonly occur

  • Itching
  • Hives
  • Congestion
  • Numbness
  • Dizziness
  • Bloody or cloudy urine
  • Dry throat
  • Frequent urge to urinate
  • Tender, swollen glands in the neck
  • Body aches or pain
  • Hoarseness
  • Voice changes
  • Puffiness or swelling of the face, lips, tongue, eyelids or area around the eyes
  • Runny nose
  • Rash on the skin
  • Difficulty swallowing
  • Tingling sensation
  • Feeling unusually tired or weak
  • Fast heartbeat

Other side effects may occur, but it is not known how frequently they do or how severe they may be. Some of them are as follows:

Incidence unknown

  • Tremor
  • Eye tenderness
  • Eye pain (severe)
  • Teary eyes
  • Cramps in the stomach or abdomen
  • Vision changes (including blurred vision)
  • Pain in the muscle, bone or joint (severe and sometimes incapacitating)
  • Confusion
  • Redness of the eye
  • Feeling of heaviness in the jaw
  • Irregular heartbeats
  • Loose tooth
  • Convulsions
  • Cramping of the muscles in the face, hands, arms, legs or feet
  • Noisy breathing
  • Tingling or numbness in the feet, fingertips or around the mouth
  • Numbness, swelling or pain in the mouth or jaw
  • Sensitivity to light
  • Teary eyes
  • Unusual pain in the hips, thighs or groin
  • Large, hive-like swelling of the face, lips, tongue, throat, eyelids, hands, feet, legs or sex organs

There are side effects that do not need medical attention if they occur. As the body gets used to the medicine, these effects tend to go away eventually.

Talk with your doctor if any of the following side effects occur but become bothersome or do not go away.

More commonly occur

  • Loss of voice
  • Ear congestion
  • Headache
  • Diarrhea
  • Pain in the arms and legs (very severe)

Less commonly occur

  • Muscle aches and pain
  • Difficulty moving the bowel (stool)
  • Muscle stiffness
  • Trouble sleeping
  • Feeling as if you (or your surroundings) are moving
  • Feeling of sadness or emptiness
  • General feeling of illness or discomfort
  • Sweating
  • Feeling lightheaded
  • Feeling as if you are spinning
  • Joint pain
  • Lack of interest or pleasure
  • Shivering
  • Difficulty moving
  • Redness, pain or swelling of the joints
  • Lack or loss of strength
  • Tooth problems
  • Stuffy nose
  • Feeling irritable
  • Cough
  • Trouble concentrating
  • Feeling discouraged

Some patients may experience other side effects not listed in this guide. Tell your doctor if you notice any unusual symptom that bothers you or becomes worse.

For more information on side effects and how to reduce or prevent them, ask your doctor or healthcare professional.

You may also call the FDA at 1-800-FDA-1088 to report side effects.

Dosage

Dosage directions will be on the prescription label of your medicine. It usually tells you the strength of your dose, the time between each dose, how often you should take it, and the duration of your treatment.

Follow those and other directions given to you by your doctor or pharmacist. The patient information leaflet may also have additional information to guide you.

In addition to your medicine, your doctor may instruct you to eat a well-balanced diet that includes an adequate intake of calcium and vitamin D.

The following is only a recommended dosage guide. You should stick to the dosage directions given to you by your doctor.

For treating and preventing post-menopausal osteoporosis:

Adults: Take 2.5 milligrams (mg) once a day in the morning. It can also be taken monthly instead of daily. Take 150 mg once a month on the same date of each month. Swallow the tablet whole; sucking or chewing it may cause your esophagus to become irritated.

Children: Treatment with Ibandronate must be determined by your doctor.

Ibandronate should be taken as soon as you wake in the morning, and at least 1 hour before eating, drinking or taking other medicines. Take it with a full glass of plain water (6 to 8 ounces).

If you are able to wait longer than 60 minutes before you eat, drink or take other medicines, this will increase the effectiveness of the drug.

Taking food and certain beverages, such as coffee, milk, tea, juice or mineral water prevents the medicine from being properly absorbed in the body and reduces its effectiveness.

Calcium or vitamin supplements and other medicines, such as antacids, reduce absorption of the drug if used around the time of taking Ibandronate.

Missed dose

If you are a patient taking daily doses of the medication and you missed a dose, you should skip the missed dose and take the medicine the following morning. Afterwards, continue with the regular dosing schedule. Do not take two tablets on the same day.

If you are taking the medicine once per month, you should take your dose early the next morning after you remember you missed a dose. But you should take it only if the next scheduled dose is 7 or more days away.

Afterwards, take the next dose on the exact day of the month you are supposed to take it.

However, if the next dose is 1 to 7 days away skip the missed dose and take your medicine on the next scheduled day. Continue with the regular schedule afterward.

Overdose

Call your doctor, 911 and/or the local poison control center at 1-800-222-1222, if you overdose on this drug. If the patient collapses or is not breathing, call 911.

The following are symptoms of an overdose. Seek emergency medical care right away if you experience them:

Symptoms of overdose

  • Indigestion
  • Belching
  • Tenderness in the stomach area
  • Vomiting
  • Sour or acid stomach
  • Loss of appetite
  • Burning sensation or pain in the throat
  • Sores or ulcers
  • Bone pain
  • Pain or discomfort in the stomach or upset stomach
  • Heartburn
  • White spots inside the mouth or on the tongue or lips
  • Burning sensation in the chest or stomach

Interactions

Food, alcohol, tobacco and other medicines or medical problems may interact with your medicine during treatment. Your doctor will consider your medical history and medicines or other substances you may be taking when deciding to treat you.

The following foods, medicines, and medical problems are listed because they may cause significant interaction with Ibandronate.

Food, alcohol or tobacco

Your doctor may caution you on the use of food, alcohol, or tobacco.

There may be an increased risk of certain side effects if the following are used when taking the medicine. If using them cannot be avoided, your doctor may change the dose or how often you use your medicine. You may also be given special directions on their use.

  • Food
  • Dairy food

Other medicines

The medicine should be used with caution in patients who are taking other drugs that may make gastrointestinal irritation worse. They include aspirin or nonsteroidal anti-inflammatory medicines.

Other medicines not mentioned here may also cause interaction.

Other medical problems

The following conditions may affect or be affected by this medicine if they are present in patients being treated with Ibandronate.

This medicine should not be used in patients with any of these conditions:

  • Trouble with swallowing
  • Kidney disease (severe)
  • Inability to sit upright or stand for at least 60 minutes
  • Low calcium in the blood (Hypocalcemia)
  • Problems of the esophagus (the muscular tube that connects the throat to the stomach) e.g. stricture or achalasia

The medicine may increase the risk of jaw problems in patients who have the following:

  • Infection
  • Cancer
  • Anemia
  • Poor oral hygiene
  • Blood clotting problems
  • Dental procedures (such as tooth extraction or dental implants)
  • Surgery (e.g. dental surgery)
  • Dental or tooth problems

Use Ibandronate with caution in patients who have the following conditions as it may make these conditions worse:

  • Stomach or bowel problems (such as Barrett's esophagus, gastritis, inflammation of the esophagus, heartburn, ulcers or duodenitis)

You may ask your doctor for information on other medical conditions that may cause adverse interaction with this medicine.

Warnings

  • Do not use Ibandronate to treat post-menopausal osteoporosis unless it was prescribed for you.
  • Do not use it if you are allergic to it or any of its inactive ingredients.
  • Tell your doctor if you are allergic to other medicines, foods, dyes, preservatives, or animals.
  • This medicine should not be used to treat children because its safety and efficacy have not been established.
  • Due to inadequate studies, it is not known whether the drug can harm an unborn baby or a breastfeeding infant.

Therefore, do not use this medicine if you are pregnant or breastfeeding unless your doctor determines the potential benefits outweigh the risks.

  • Do not use other medicines while taking Ibandronate unless your doctor approves.
  • Let your doctor know about all prescription or non-prescription medicines, vitamins, and nutritional or herbal supplements you plan to take.
  • Tell your doctor about any other medical problems you have so your doctor can determine if and how to treat you. This is necessary as medical problems may cause adverse interaction with the medicine.
  • Ibandronate should not be used by individuals with esophagus abnormalities.
  • Do not chew or suck the tablet. Instead, swallow it whole to avoid irritation of your esophagus.
  • Stop taking Ibandronate and call your doctor if you think the medicine is causing irritation or damage to your esophagus.

Symptoms of damage include pain or difficulty when swallowing, heartburn, feeling as if food is stuck after you swallow it, or pain in the center of the chest.

  • Do not take food, beverages or other medicines such as antacids, vitamin supplements or calcium around the time you take Ibandronate. This may affect the way the medicine works and reduce the amount of medicine the body absorbs.
  • To allow the medicine to reach your stomach faster and prevent irritation of your esophagus, avoid lying down before 60 minutes have passed since you took the medicine.
  • Tell your doctor if you are on any special diet such as one that requires low sugar or low sodium intake.
  • You should not stop using the drug suddenly. Speak with your doctor for advice on how to stop using it.
  • Also tell your doctor immediately if you have symptoms of low calcium, such as tingling or numbness in your toes, fingers, or lips, twitching or muscle spasms.
  • Do not undergo any medical or dental surgery or procedure before telling your doctor or the person doing the procedure that you are taking this drug. A dental procedure may increase your risk of severe jaw problems.
  • Tell your doctor if you develop new medical conditions, particularly with your teeth or jaws, or if you have pain in the muscle, bone or joint while taking the medicine.
  • The risk of thigh bone fractures may increase during your treatment. If you feel a dull or aching pain in the hips, thighs or groin, call your doctor right away.
  • Keep all follow-up appointments so your doctor can monitor your progress and check for side effects.

Storage

Keep the medicine stored in a closed container away from heat, moisture, and direct light. Keep and freezing.

Keep out of the reach of children.

Throw away medicine that is expired or no longer needed.

Ask your healthcare professional or local waste disposal agency how to safely dispose of it.

Summary

Ibandronate is a safe and effective medicine for treating and preventing osteoporosis in women who have passed menopause. Its use in the improvement of bone health is especially important since it reduces bone loss and the risk of bone fractures.

A balanced diet with adequate calcium and vitamin D helps improve the effectiveness of the medicine.

One of the major side effects of using this medicine is the risk of developing problems with the esophagus, teeth, and jaws. As such, patients are required to follow the directions for using this tablet very closely to reduce the risks of these effects.

Ibandronate is sensitive to foods, beverages, or other medicines, vitamins or supplements taken by the patient around the time of taking their dose. Absorption of the medicine by the body may be significantly affected, causing it to lose its full effect.

Incidentally, although this medicine helps reduce certain bone fractures, it also increases the risk of thigh bone fractures.