Atelvia is a bisphosphonate medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures.

Atelvia is a prescription medicine used in women to treat osteoporosis caused by menopause.

It is not known how long Atelvia works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if this medicine is still right for you.

You should not take Atelvia if you have problems with your esophagus, or low levels of calcium in your blood.

Do not take this medicine if you cannot sit upright or stand for at least 30 minutes after taking the medicine.

Atelvia can cause serious problems in the stomach or esophagus. Stop using this medicine and call your doctor at once if you have chest pain, new or worsening heartburn, or pain when swallowing.

Also call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.

Atelvia side effects

Get emergency medical help if you have signs of an allergic reaction to Atelvia (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Stop using Atelvia and call your doctor at once if you have:

• chest pain, new or worsening heartburn;

• difficulty or pain when swallowing;

• pain or burning under the ribs or in the back;

• severe heartburn, burning pain in your upper stomach, or coughing up blood;

• new or unusual pain in your thigh or hip;

• jaw pain, numbness, or swelling;

• severe joint, bone, or muscle pain; or

• low calcium levels - muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common Atelvia side effects may include:

• heartburn, diarrhea, indigestion;

• stomach pain;

• back pain, joint pain, muscle pain; or

• flu-like symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take Atelvia exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Risedronate is often given for only 3 to 5 years.

Take the tablet just after breakfast, with at least 4 ounces of water.

Swallow Atelvia tablets whole. Do not chew, cut, or crush the tablets before swallowing. If you cannot swallow the tablets whole, tell your doctor. You may need a different medicine.

For at least 30 minutes after taking Atelvia:

• Do not lie down or recline. You may sit, stand or walk, and do normal activities like reading.

• Do not take any other medicine including vitamins, calcium, iron, antacids, or laxatives.

Take this medicine at the same time each day or on the same day each week or each month (depending on your dosing schedule).

Pay special attention to your dental hygiene while taking Atelvia. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using risedronate.

Atelvia is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin supplements. Follow your doctor's instructions very closely.

Store at room temperature away from moisture and heat. Keep unused effervescent tablets in the foil blister pack.

Usual Adult Dose for Osteoporosis:

Treatment of Postmenopausal Osteoporosis:
Delayed release:
-35 mg orally once a week


Comments:
-Refer to administration advice for details on how to take this drug.
-Reevaluate bisphosphonate therapy periodically.
-Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

Uses:
-Treatment to reduce the incidence of vertebral fractures and composite endpoint of nonvertebral osteoporosis-related fractures in postmenopausal women.

You should not take Atelvia if you are allergic to risedronate, or if you have:

• low levels of calcium in your blood (hypocalcemia); or

• problems with the muscles in your esophagus (the tube that connects your mouth and stomach).

Do not take Atelvia if you cannot sit upright or stand for at least 30 minutes. Risedronate can cause serious problems in the stomach or esophagus. You must stay upright for at least 30 minutes after taking this medicine.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• trouble swallowing;

• problems with your stomach or digestion;

• hypocalcemia;

• a dental problem (you may need a dental exam before you begin taking Atelvia);

• kidney disease; or

• any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

Risedronate may cause jaw bone problems (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people treated with steroids, chemotherapy, or radiation. Ask your doctor about your own risk.

Talk with your doctor about the risks and benefits of using Atelvia.

It is not known whether risedronate will harm an unborn baby. Stop taking Atelvia and tell your doctor right away if you become pregnant, or think you may be pregnant.

You should not breastfeed while using Atelvia.

Risedronate should not be given to a child younger than 18 years old.

If you forget to take Atelvia on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take 2 doses in one day.

Call your doctor for instructions if you miss more than 2 doses in a month.

Drink a full glass of milk and seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Do not make yourself vomit and do not lie down.

Avoid taking any other medicines for at least 30 minutes after taking Atelvia. This includes vitamins, calcium, iron, antacids, or laxatives. Some medicines can make it harder for your body to absorb risedronate.

Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.

Get emergency medical help if you have signs of an allergic reaction to Atelvia (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Stop using Atelvia and call your doctor at once if you have:

• chest pain, new or worsening heartburn;

• difficulty or pain when swallowing;

• pain or burning under the ribs or in the back;

• severe heartburn, burning pain in your upper stomach, or coughing up blood;

• new or unusual pain in your thigh or hip;

• jaw pain, numbness, or swelling;

• severe joint, bone, or muscle pain; or

• low calcium levels - muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common Atelvia side effects may include:

• heartburn, diarrhea, indigestion;

• stomach pain;

• back pain, joint pain, muscle pain; or

• flu-like symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• aspirin;

• calcium or iron supplements;

• antacids, laxatives; or

• NSAIDs (nonsteroidal anti-inflammatory drugs) - ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with risedronate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Talk with your doctor about the best dosing schedule for your other medicines.