IBANDRONATE SODIUM: Package Insert and Label Information (Page 4 of 4)

Once-Monthly Dosing

The safety and effectiveness of ibandronate sodium tablets 150 mg once-monthly for the prevention of postmenopausal osteoporosis were demonstrated in a randomized, double-blind, placebo-controlled 1-year study (Monthly Prevention Study) of 160 postmenopausal women with low bone mass at baseline (T-score of -1 to -2.5). Women, aged 46 to 60 years, were on average 5.4 years postmenopause. All women received 400 international units of vitamin D and 500 mg calcium supplementation daily.

The primary efficacy measure was the relative change in BMD at the lumbar spine after 1 year of treatment. Ibandronate sodium tablets 150 mg once-monthly resulted in a mean increase in lumbar spine BMD of 4.12% (95% confidence interval 2.96 to 5.28) compared with placebo following 1 year of treatment (p<0.0001), based on a 3.73% and -0.39% mean change in BMD from baseline in the 150 mg once-monthly ibandronate sodium tablets and placebo treatment groups, respectively. BMD at other skeletal sites was also increased relative to baseline values.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Ibandronate sodium 150-mg tablets are supplied as white to off-white, oval, biconvex, film-coated tablets, engraved with “APO” on one side and “IBA150” on the other side. They are supplied as follows:

Packaged in bundles of 3 boxes, each box containing 1 blister strip of 1 tablet each (NDC 60429-643-73).

16.2 Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Dispense in a tight container [see USP].

17 PATIENT COUNSELING INFORMATION

“See FDA-approved patient labeling (Medication Guide)”

17.1 Information for Patients

Instruct patients to read the Medication Guide carefully before taking ibandronate sodium tablets and to re-read it each time the prescription is renewed because it contains important information the patient should know about ibandronate sodium tablets The Medication Guide also includes the dosing instructions in order to maximize absorption and clinical benefit.

  1. Ibandronate sodium tablets should be taken at least 60 minutes before the first food or drink (other than water) of the day and before taking any oral medication or supplementation including calcium, antacids or vitamins (see DRUG INTERACTIONS [7.1]) .
  2. To facilitate delivery to the stomach, and thus reduce the potential for esophageal irritation, ibandronate sodium tablets should be swallowed whole with a full glass of plain water (6 to 8 oz) while the patient is standing or sitting in an upright position. Patients should not lie down for 60 minutes after taking ibandronate sodium tablets.
  3. Patients should not eat, drink anything except for water, or take other medications for 60 minutes after taking ibandronate sodium tablets.
  4. Plain water is the only drink that should be taken with ibandronate sodium tablets. Note that some mineral waters may have a higher concentration of calcium and therefore should not be used.
  5. Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration.
  6. The ibandronate sodium tablets 150 mg tablet should be taken on the same date each month (i.e., the patient’s ibandronate sodium tablets day).
  7. The patient must not take two 150 mg tablets within the same week.
  8. If the once-monthly dose is missed, and the patient’s next scheduled ibandronate sodium tablets day is more than 7 days away, the patient should be instructed to take one ibandronate sodium 150 mg tablet in the morning following the date that it is remembered (see DOSAGE AND ADMINISTRATION [2.3]) . The patient should then return to taking one ibandronate sodium 150 mg tablet every month in the morning of their chosen day, according to their original schedule.
  9. If the once-monthly dose is missed, and the patient’s next scheduled ibandronate sodium tablets day is only 1 to 7 days away, the patient must wait until the subsequent month’s scheduled ibandronate sodium tablets day to take their tablet. The patient should then return to taking one ibandronate sodium 150 mg tablet every month in the morning of their chosen day, according to their original schedule.

Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Intake of supplemental calcium and vitamin D should be delayed for at least 60 minutes following oral administration of ibandronate sodium tablets in order to maximize absorption of ibandronate sodium tablets.

Physicians should be alert to signs or symptoms signaling a possible esophageal reaction during therapy, and patients should be instructed to discontinue ibandronate sodium tablets and seek medical attention if they develop symptoms of esophageal irritation such as new or worsening dysphagia, pain on swallowing, retrosternal pain, or heartburn.

GSMS, Inc.
IBANDRONATE SODIUM TABLETS 150 mg

Manufactured by

Manufactured for

Marketed/ Packaged by:

Apotex Inc.

Apotex Corp.

GSMS, Inc.

Toronto, Ontario

Weston, Florida

Camarillo, CA

Canada M9L 1T9

33326

93010

Revised: February 2017

Rev. 14

MEDICATION GUIDE

Ibandronate Sodium Tablets

(eye-ban-droe-nate soe-dee-um)

Read the Medication Guide that comes with ibandronate sodium tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. Talk to your doctor if you have any questions about ibandronate sodium tablets.

What is the most important information I should know about ibandronate sodium tablets?

Ibandronate sodium tablets may 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 ibandronate sodium tablets 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 ibandronate sodium tablets exactly as prescribed to help lower your chance of getting esophagus problems (see the section “How should I take ibandronate sodium tablets?”).

Stop taking ibandronate sodium tablets 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).

Ibandronate sodium tablets may lower the calcium levels in your blood. If you have low blood calcium before you start taking ibandronate sodium tablets, it may get worse during treatment. Your low blood calcium must be treated before you take ibandronate sodium tablets. 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 ibandronate sodium tablets. Take calcium and vitamin D as your doctor tells you to.

3. Bone, joint, or muscle pain.

Some people who take ibandronate sodium tablets develop severe bone, joint, or muscle pain.

4. Severe jaw bone problems (osteonecrosis).

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

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.

What are ibandronate sodium tablets?

Ibandronate sodium tablets are a prescription medicine used to treat or prevent osteoporosis in women after menopause. Ibandronate sodium tablets help increase bone mass and helps reduce the chance of having a spinal fracture (break).

It is not known how long ibandronate sodium tablets works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if ibandronate sodium tablets are still right for you.

It is not known if ibandronate sodium tablets are safe and effective in children.

Who should not take ibandronate sodium tablets?

Do not take ibandronate sodium tablets 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 ibandronate sodium tablets or any of its ingredients. A list of ingredients is at the end of this leaflet

What should I tell my doctor before taking ibandronate sodium tablets?

Before you start ibandronate sodium tablets, be sure to talk to your doctor 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)

• Are pregnant, or plan to become pregnant. It is not known if ibandronate sodium tablets can harm your unborn baby.

• Are breast-feeding or plan to breast-feed. It is not known if ibandronate sodium passes into your milk and may harm your baby.

Tell your doctor and dentist about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Certain medicines may affect how ibandronate sodium tablets works.

Especially tell your doctor if you take:

• antacids

• aspirin

• Nonsteroidal Anti-Inflammatory (NSAID) medicines

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine.

How should I take ibandronate sodium tablets?

• Take ibandronate sodium tablets exactly as your doctor tells you.

• Take 1 ibandronate sodium tablets 150 mg tablet 1 time every month on the same day each month.

Ibandronate sodium tablets work only if taken on an empty stomach.

• Take 1 ibandronate sodium tablet, after you get up for the day and before taking your first food, drink, or other medicine.

• Take ibandronate sodium tablets while you are sitting or standing.

Do not chew or suck on a tablet of ibandronate sodium tablets.

• Swallow ibandronate sodium tablet with a full glass (6 to 8 oz) of plain water only.

• Do not take ibandronate sodium tablets with mineral water, coffee, tea, soda, or juice.

After swallowing ibandronate sodium tablet, wait at least 60 minutes:

• Before you lie down. You may sit, stand or walk, and do normal activities like reading.

• Before you take your first food or drink except for plain water.

• Before you take other medicines, including antacids, calcium, and other supplements and vitamins.

Do not lie down for at least 60 minutes after you take ibandronate sodium tablets and do not eat your first food of the day for at least 60 minutes after you take ibandronate sodium tablets.

If you miss a dose of ibandronate sodium tablets, do not take it later in the day. Call your doctor for instructions.

If you take too much ibandronate sodium tablets, call your doctor. Do not try to vomit. Do not lie down.

What are the possible side effects of ibandronate sodium tablets?

Ibandronate sodium tablets may cause serious side effects.

• See “What is the most important information I should know about ibandronate sodium tablets?”

The most common side effects of ibandronate sodium tablets are:

• 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, breathing difficulties, swelling of your face, lips, tongue or throat, or feeling faint.

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 ibandronate sodium tablets. For more information, ask your doctor or pharmacist.

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

How do I store ibandronate sodium tablets?

• Store ibandronate sodium tablets at room temperature, 59°F to 86°F (15°C to 30°C).

• Keep ibandronate sodium tablets in a tightly closed container.

Keep ibandronate sodium tablets and all medicines out of the reach of children.

General information about the safe and effective use of ibandronate sodium tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ibandronate sodium tablets for a condition for which it was not prescribed. Do not give ibandronate sodium tablets to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about ibandronate sodium tablets.

If you would like more information, talk with your doctor.

You can ask your doctor or pharmacist for information about ibandronate sodium tablets that is written for health professionals.

For more information, go to www.apotex.com or call 1-800-706-5575

What are the ingredients of ibandronate sodium tablets?

Active ingredient: ibandronate sodium

Inactive ingredients: microcrystalline cellulose, crospovidone, magnesium stearate, and colloidal silicon dioxide. The tablet film coating contains hypromellose, polyethylene glycol 8000 and purified water.

This Medication Guide has been approved by the U.S. Food and Drug Administration

INSTRUCTIONS FOR OPENING:

1. Peel back the paper layer that covers the ibandronate sodium tablet on the blister card. Foil layer becomes exposed.

Ensure that the paper layer is completely removed from the area over tablet.

http://druginserts.com/lib/images-rx/ibandronate-sodium-18/instructions1.jpg

2. With clean and dry hands, carefully press on the clear plastic film to push tablet through foil.

http://druginserts.com/lib/images-rx/ibandronate-sodium-18/instructions2.jpg

GSMS, Inc.
IBANDRONATE SODIUM TABLETS 150 mg

Manufactured by

Manufactured for

Marketed/ Packaged by:

Apotex Inc.

Apotex Corp.

GSMS, Inc.

Toronto, Ontario

Weston, Florida

Camarillo, CA

Canada M9L 1T9

33326

93010

Revised: February 2017

Rev. 14

PRINCIPAL DISPLAY PANEL — 150 mg CARTON LABEL

GSMS, Inc.

NDC No. 60429-643-73

Ibandronate Sodium Tablet

Each tablet contains 196 mg of ibandronate sodium propylene glycol solvate equivalent to 160.25 mg ibandronate sodium or 150 mg of ibandronic acid.

150 mg

Rx Only

1 tablet

//druginserts.com/lib/images-rx/ibandronate-sodium-18/ibandronate-sodium-150-mg-tabs-rev-aug-2015-252x300.jpg
(click image for full-size original)
IBANDRONATE SODIUM ibandronate sodium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-643(NDC:60505-2795)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBANDRONATE SODIUM (IBANDRONIC ACID) IBANDRONIC ACID 150 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (15 MPA.S AT 5%)
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL 8000
WATER
Product Characteristics
Color white Score no score
Shape OVAL Size 14mm
Flavor Imprint Code APO;IBA150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-643-73 3 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the PACKAGE (60429-643-73)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078948 02/05/2016
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 repack (60429-643), relabel (60429-643)

Revised: 11/2018 Golden State Medical Supply, Inc.

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