Ibandronate (Oral Route, Injection Route)

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients and there is no specific information comparing use of ibandronate in children with use in other age groups.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Dairy Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or


• Blood clotting problems or


• Cancer or


• Cancer treatment or


• Dental or oral disease or


• Infectiona€”May put you at risk for a serious jaw problem .

• Asian or Caucasian race or


• Family history of osteoporosis or


• Other bone problems or


• Previous broken bone or


• Smoking or


• Thin body framea€”These conditions may make it more difficult for this medicine to prevent osteoporosis.

• Digestion problemsa€”Taking ibandronate may be harmful to the esophagus, intestine, or stomach.

• Esophagus problems or


• Intestine problems or


• Stomach problemsa€”Ibandronate may make these conditions worse.

• Hypocalcemia (low calcium levels in the blood)a€”Must be treated first, before beginning treatment with ibandronate.

• Inability to stand or sit upright for at least 60 minutesa€”You should not take this medicine because it could cause serious problems to your esophagus and stomach.

• Kidney problemsa€”The effects of ibandronate may be increased .

Proper Use

Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet. Your doctor may recommend that you eat a balanced diet with an adequate amount of calcium and vitamin D (found in milk or other dairy products).

Take ibandronate with a full glass (6 to 8 ounces) of plain water on an empty stomach. It should be taken in the morning at least 60 minutes before any food, beverage, or other medicines. Food and beverages, such as mineral water, coffee, tea, or juice, will decrease the amount of ibandronate absorbed by the body . Waiting longer than 60 minutes will allow more of the drug to be absorbed . Medicines such as antacids, calcium or vitamin supplements will also decrease the absorption of ibandronate.

Do not lie down for 60 minutes after taking ibandronate. This will help ibandronate reach your stomach faster. It will also help prevent irritation to your esophagus .

It is important that you eat a well-balanced diet with an adequate amount of calcium and vitamin D . However, do not take any food, beverages, or calcium or vitamin supplements within 60 minutes or longer of taking ibandronate. To do so may keep this medicine from working properly.

Swallow the tablet whole. Do not crush, break, chew, or suck it.

For the injection: You will receive this medicine from a healthcare professional every 3 months. You should not receive this injection more often than every 3 months.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  
  
  • For treatment of postmenopausal osteoporosis (thinning of bone)
    
    
    
    • Adultsa€”2.5 milligrams (mg) once a day in the morning or 150 mg once a month on the same date each month, taken at least 60 minutes before the first food, beverage, or medication . You should take ibandronate with six to eight ounces of plain water .
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • For prevention of postmenopausal osteoporosis (thinning of bone)
    
    
    
    • Adultsa€”2.5 mg once a day in the morning or 150 mg once a month on the same date each month (if directed by your doctor), taken at least 60 minutes before the first food, beverage, or medication . You should take ibandronate with six to eight ounces of plain water .
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is important that your doctor check your progress at regular visits to make sure this medicine is working properly and watch for unwanted effects.

Tell your doctor right away if you develop symptoms of your esophagus being irritated such as new or worsening difficulty swallowing, pain on swallowing, pain behind your breast bone, or heartburn. Using aspirin or nonsteroidal anti-inflammatory drugs (e.g. AleveA®, MotrinA®) may also increase your risk for stomach problems .

It is important that you tell all of your health care providers that you are taking ibandronate. If you are having a dental procedure while taking ibandronate, you may have an increased chance of having a severe problem with your jaw .

Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe bone, joint, or muscle pain while using this medicine.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor immediately if any of the following side effects occur:

More common

• Bladder pain


• Bloody or cloudy urine


• Chest pain


• Cough producing mucus


• Difficult, burning, or painful urination


• Difficulty breathing


• Fever or chills


• Frequent urge to urinate


• Lower back or side pain


• Nervousness


• Pounding in the ears


• Shortness of breath


• Slow or fast heartbeat


• Sneezing


• Sore throat


• Tightness in chest


• Wheezing

Less common

• Bloody or cloudy urine


• Body aches or pain


• Congestion


• Difficult, burning, or painful urination


• Difficulty swallowing


• Dizziness


• Dryness of throat


• Fast heartbeat


• Frequent urge to urinate


• Hives


• Hoarseness


• Itching


• Large amount of cholesterol in the blood


• Numbness


• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• Runny nose


• Skin rash


• Tender, swollen glands in neck


• Tingling


• Trouble in swallowing


• Unusual tiredness or weakness


• Voice changes

Incidence unknown

• Blurred vision or other change in vision


• Bone, joint, and/or muscle pain, severe and occasionally incapacitating


• Eye redness


• Eye tenderness


• Heavy jaw feeling


• Loosening of a tooth


• Pain, swelling, or numbness in the mouth or jaw


• Sensitivity to light


• Severe eye pain


• Tearing

Symptoms of overdose

Get emergency help immediately if any of the following symptoms of overdose occur:

• Abdominal cramps


• Acid or sour stomach


• Belching


• Bone pain


• Burning feeling in chest or stomach


• Chest pain


• Confusion


• Convulsions


• Difficulty in breathing


• Difficulty in swallowing


• Heartburn


• Indigestion


• Irregular heartbeats


• Loss of appetite


• Mood or mental changes


• Muscle cramps in hands, arms, feet, legs, or face


• Numbness and tingling around the mouth, fingertips, or feet; pain or burning in throat


• Shortness of breath


• Sores, ulcers


• Stomach discomfort, upset, or pain


• Tenderness in stomach area


• Tremor


• Ulcer


• Unusual tiredness or weakness


• Vomiting


• White spots on lips or tongue or inside the mouth

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea


• Ear congestion


• Headache


• Loss of voice


• Pain in extremity (arms and legs)

Less common

• Abdominal or stomach pain


• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site


• Cough


• Difficulty having a bowel movement [stool]


• Difficulty in moving


• Discouragement


• Feeling of constant movement of self or surroundings


• Feeling sad or empty


• General feeling of discomfort or illness


• Irritability


• Joint pain


• Lack of appetite


• Lack or loss of strength


• Lightheadedness


• Loss of interest or pleasure


• Muscle aches and pain


• Muscle pain or stiffness


• Nausea


• Pain, swelling, or redness in joints


• Sensation of spinning


• Shivering


• Stuffy nose


• Sweating


• Tooth disorder


• Trouble concentrating


• Trouble sleeping

Rare

• Sleeplessness


• Unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.