FOSAMAX PLUS D (Page 8 of 9)

14.2 Treatment to Increase Bone Mass in Men with Osteoporosis

The efficacy of FOSAMAX in men with hypogonadal or idiopathic osteoporosis was demonstrated in two clinical studies.

FOSAMAX Daily

A two-year, double-blind, placebo-controlled, multicenter study of FOSAMAX 10 mg once daily enrolled a total of 241 men between the ages of 31 and 87 (mean, 63). All patients in the trial had either a BMD T-score less than or equal to -2 at the femoral neck and less than or equal to -1 at the lumbar spine, or a baseline osteoporotic fracture and a BMD T-score less than or equal to -1 at the femoral neck. At two years, the mean increases relative to placebo in BMD in men receiving FOSAMAX 10 mg/day were significant at the following sites: lumbar spine, 5.3%; femoral neck, 2.6%; trochanter, 3.1%; and total body, 1.6%. Treatment with FOSAMAX also reduced height loss (FOSAMAX, -0.6 mm vs. placebo, -2.4 mm).

FOSAMAX Once-Weekly

A one-year, double-blind, placebo-controlled, multicenter study of once weekly FOSAMAX 70 mg enrolled a total of 167 men between the ages of 38 and 91 (mean, 66). Patients in the study had either a BMD T-score less than or equal to -2 at the femoral neck and less than or equal to -1 at the lumbar spine, or a BMD T-score less than or equal to -2 at the lumbar spine and less than or equal to -1 at the femoral neck, or a baseline osteoporotic fracture and a BMD T-score less than or equal to -1 at the femoral neck. At one year, the mean increases relative to placebo in BMD in men receiving FOSAMAX 70 mg once weekly were significant at the following sites: lumbar spine, 2.8%; femoral neck, 1.9%; trochanter, 2.0%; and total body, 1.2%. These increases in BMD were similar to those seen at one year in the 10 mg once-daily study.

In both studies, BMD responses were similar regardless of age (greater than or equal to 65 years vs. less than 65 years), gonadal function (baseline testosterone less than 9 ng/dL vs. greater than or equal to 9 ng/dL), or baseline BMD (femoral neck and lumbar spine T-score less than or equal to -2.5 vs. greater than -2.5).

16 HOW SUPPLIED/STORAGE AND HANDLING

FOSAMAX PLUS D 70 mg/2800 international units are white to off-white, modified capsule-shaped tablets with code 710 on one side and an outline of a bone image on the other. They are supplied as follows:

NDC 78206-137-01 unit of use blister packages of 4.

FOSAMAX PLUS D 70 mg/5600 international units are white to off-white, modified rectangle-shaped tablets with code 270 on one side and an outline of a bone image on the other. They are supplied as follows:

NDC 78206-136-01 unit of use blister packages of 4

Storage

Store at 20-25°C (68-77°F), excursions between 15-30°C (59-86°F) are allowed. [See USP Controlled Room Temperature.] Protect from moisture and light. Store tablets in the original blister package until use.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Instruct patients to read the Medication Guide before starting therapy with FOSAMAX PLUS D and to reread it each time the prescription is renewed.

17.1 Osteoporosis Recommendations, Including Calcium and Vitamin D Supplementation

Instruct patients to take supplemental calcium if intake is inadequate. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home bound, or chronically ill) should take additional vitamin D if needed [see Dosage and Administration (2.4)]. Patients with gastrointestinal malabsorption syndromes may require additional vitamin D supplementation. Weight-bearing exercise should be considered along with the modification of certain behavioral factors, such as cigarette smoking and/or excessive alcohol consumption, if these factors exist.

17.2 Dosing Instructions

Instruct patients that the expected benefits of FOSAMAX PLUS D may only be obtained when it is taken with plain water the first thing upon arising for the day at least 30 minutes before the first food, beverage, or medication of the day. Even dosing with orange juice or coffee has been shown to markedly reduce the absorption of alendronate [see Clinical Pharmacology (12.3)].

Instruct patients not to chew or suck on the tablet because of a potential for oropharyngeal ulceration.

Instruct patients to swallow each tablet of FOSAMAX PLUS D with a full glass of water (6-8 ounces) and not to lie down for at least 30 minutes and until after their first food of the day to facilitate delivery to the stomach and thus reduce the potential for esophageal irritation.

Instruct patients not to take FOSAMAX PLUS D at bedtime or before arising for the day. Patients should be informed that failure to follow these instructions may increase their risk of esophageal problems.

Instruct patients that if they develop symptoms of esophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn) they should stop taking FOSAMAX PLUS D and consult their physician.

If patients miss a dose of FOSAMAX PLUS D, instruct patients to take one tablet on the morning after they remember. They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.

Dist. by: Organon LLC, a subsidiary of
ORGANON & Co.,
Jersey City, NJ 07302, USA

For patent information: www.organon.com/our-solutions/patent/

© 2021 Organon group of companies. All rights reserved.

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MEDICATION GUIDE
FOSAMAX® PLUS D (FOSS-ah-max PLUS D)
(alendronate sodium/cholecalciferol)
Tablets

Read the Medication Guide that comes with FOSAMAX® PLUS D 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 treatment. Talk to your doctor if you have any questions about FOSAMAX PLUS D.

What is the most important information I should know about FOSAMAX PLUS D?

FOSAMAX PLUS D 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 FOSAMAX PLUS D 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 FOSAMAX PLUS D exactly as prescribed to help lower your chance of getting esophagus problems. (See the section “How should I take FOSAMAX PLUS D tablet?”)
    • Stop taking FOSAMAX PLUS D 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).
    FOSAMAX PLUS D may lower the calcium levels in your blood. If you have low blood calcium before you start taking FOSAMAX PLUS D, it may get worse during treatment. Your low blood calcium must be treated before you take FOSAMAX PLUS D. 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 FOSAMAX PLUS D. Take calcium and vitamin D as your doctor tells you to.

  3. Bone, joint, or muscle pain.
    Some people who take FOSAMAX PLUS D develop severe bone, joint, or muscle pain.
  4. Severe jaw bone problems (osteonecrosis).
    Severe jaw bone problems may happen when you take FOSAMAX PLUS D. Your doctor should examine your mouth before you start FOSAMAX PLUS D. Your doctor may tell you to see your dentist before you start FOSAMAX PLUS D. It is important for you to practice good mouth care during treatment with FOSAMAX PLUS D.
  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 is FOSAMAX PLUS D?

FOSAMAX PLUS D is a prescription medicine used to:

  • Treat osteoporosis in women after menopause. FOSAMAX PLUS D helps increase bone mass and reduces the chance of having a hip or spinal fracture (break).
  • Increase bone mass in men with osteoporosis.

FOSAMAX PLUS D should not be used to treat vitamin D deficiency.

It is not known how long FOSAMAX PLUS D works for the treatment of osteoporosis. You should see your doctor regularly to determine if FOSAMAX PLUS D is still right for you.

FOSAMAX PLUS D is not for use in children.

Who should not take FOSAMAX PLUS D?

Do not take FOSAMAX PLUS D 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 30 minutes
  • Have low levels of calcium in your blood
  • Are allergic to FOSAMAX PLUS D or any of its ingredients. A list of ingredients is at the end of this leaflet.

What should I tell my doctor before taking FOSAMAX PLUS D?

Before you start FOSAMAX PLUS D, 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 sarcoidosis, leukemia, lymphoma. These conditions may cause changes in vitamin D.
  • Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
  • Are pregnant, trying to become pregnant or suspect that you are pregnant. If you become pregnant while taking FOSAMAX PLUS D, stop taking it and contact your doctor. It is not known if FOSAMAX PLUS D can harm your unborn baby.
  • Are breast-feeding or plan to breast-feed. It is not known if FOSAMAX PLUS D passes into your milk and may harm your baby.

Especially tell your doctor if you take:

  • antacids
  • aspirin
  • Nonsteroidal Anti-Inflammatory (NSAID) medicines

Tell your doctor about all the medicines you take , including prescription and non-prescription medicines, vitamins, and herbal supplements. Certain medicines may affect how FOSAMAX PLUS D works.

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 FOSAMAX PLUS D tablet?

  • Take FOSAMAX PLUS D exactly as your doctor tells you.
  • FOSAMAX PLUS D works only if taken on an empty stomach.
  • Take 1 dose of FOSAMAX PLUS D 1 time a week, after you get up for the day and before taking your first food, drink, or other medicine.
  • Take FOSAMAX PLUS D while you are sitting or standing.
  • Take your FOSAMAX PLUS D tablet with a full glass (6-8 oz) of plain water.
  • Do not chew or suck on a tablet of FOSAMAX PLUS D.
  • Do not take FOSAMAX PLUS D with mineral water, coffee, tea, soda, or juice.
  • Do not take FOSAMAX PLUS D at bedtime.

After swallowing FOSAMAX PLUS D, wait at least 30 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 30 minutes after you take FOSAMAX PLUS D and after you eat your first food of the day.

If you miss a dose of FOSAMAX PLUS D, do not take it later in the day. Take your missed dose on the next morning after you remember and then return to your normal schedule. Do not take 2 doses on the same day.

If you take too much FOSAMAX PLUS D, call your doctor. Do not try to vomit. Do not lie down.

What are the possible side effects of FOSAMAX PLUS D?

FOSAMAX PLUS D may cause serious side effects.

  • See “What is the most important information I should know about FOSAMAX PLUS D?”

The most common side effects of FOSAMAX PLUS D are:

  • Stomach area (abdominal) pain
  • Heartburn
  • Constipation
  • Diarrhea
  • Upset stomach
  • Pain in your bones, joints, or muscles
  • Nausea

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

Worsening of asthma has been reported.

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 FOSAMAX PLUS D. 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 FOSAMAX PLUS D?

  • Store FOSAMAX PLUS D at room temperature, 68°F to 77°F (20°C to 25°C).
  • Keep FOSAMAX PLUS D away from light.
  • Keep FOSAMAX PLUS D package and tablets dry.
  • Store FOSAMAX PLUS D in the original package.

Keep FOSAMAX PLUS D and all medicines out of the reach of children.

General information about the safe and effective use of FOSAMAX PLUS D.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FOSAMAX PLUS D for a condition for which it was not prescribed. Do not give FOSAMAX PLUS D 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 FOSAMAX PLUS D. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about FOSAMAX PLUS D that is written for health professionals.

What are the ingredients in FOSAMAX PLUS D?

Active ingredients: alendronate sodium and cholecalciferol (vitamin D3 ).

Inactive ingredients: cellulose, lactose, medium chain triglycerides, gelatin, croscarmellose sodium, sucrose, colloidal silicon dioxide, magnesium stearate, butylated hydroxytoluene, modified food starch, and sodium aluminum silicate.

Dist. by: Organon LLC, a subsidiary of
ORGANON & Co.,
Jersey City, NJ 07302, USA

For patent information: www.organon.com/our-solutions/patent/

© 2021 Organon group of companies. All rights reserved.

Revised: 8/2021

usmg-og0217a-t-2108r001

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