Bonsity

Bonsity is a prescription medication used to treat certain patients who have osteoporosis. Bonsity is approved to treat postmenopausal women who have osteoporosis and are at a high risk for fracture, to increase bone mass in men who have primary or hypogonadal osteoporosis and are at a high risk for fracture, and to treat both men and women who have osteoporosis associated with sustained systemic glucocorticoid therapy who are at a high risk for fracture.

Bonsity comes in an injectable form in a pre-assembled delivery device. Bonsity is injected just under the skin (subcutaneously) in the thigh or lower stomach area once daily, for up to 28 days of treatment. The injection can be self-administered or administered by a caregiver. 

Common side effects include nausea, joint aches and pain.

Bonsity is a prescription medicine that is like a hormone made by the body called parathyroid hormone or PTH. Bonsity may help to form new bone, increase bone mineral density and bone strength.

Bonsity can lessen the number of fractures of the spine and other bones in postmenopausal women with osteoporosis.

The effect on fractures has not been studied in men.

Bonsity is used in both men and postmenopausal women with osteoporosis who are at high risk for having fractures. Bonsity can be used by people who have had a fracture related to osteoporosis, or who have several risk factors for fracture, or who cannot use other osteoporosis treatments.

Bonsity is used in both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones (fractures). These include men and women with either a history of broken bones, who have several risk factors for fracture, or who cannot use other osteoporosis treatments.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Bonsity. See the "Bonsity Precautions" section.

Common side effects include nausea, joint aches and pain.

This is not a complete list of Bonsity side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or does not go away.

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

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider needs this information to help keep you from taking Bonsity with other medicines that may harm you.

Especially tell your doctor if you take medicines that contain digoxin (brand names Digoxin, Lanoxicaps, and Lanoxin).

This is not a complete list of Bonsity drug interactions. Ask your doctor or pharmacist for more information.

Bonsity may cause serious side effects including:

• Possible bone cancer. During drug testing, the medicine in Bonsity caused some rats to develop a bone cancer called osteosarcoma. In people, osteosarcoma is a serious but rare cancer. Osteosarcoma has rarely been reported in people who took Bonsity. It is not known if people who take Bonsity have a higher chance of getting osteosarcoma.

• Decrease in blood pressure when you change positions. Some people feel dizzy, get a fast heartbeat, or feel faint right after the first few doses. This usually happens within 4 hours of taking Bonsity and goes away within a few hours. For the first few doses, take your injections of Bonsity in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking Bonsity and call your healthcare provider.

• Increased calcium in your blood. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs that there is too much calcium in your blood.

Do not take Bonsity:

• for more than 2 years over your lifetime.
• if you are allergic to any of the ingredients in Bonsity.

Bonsity should not be used in children and young adults whose bones are still growing.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Bonsity, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take Bonsity, tell your healthcare provider if you:

• if you are allergic to any of the ingredients in Bonsity
• have Paget's disease or other bone disease
• have cancer in your bones
• have trouble injecting yourself and do not have someone who can help you
• are a child or young adult whose bones are still growing
• have or have had kidney stones
• have had radiation therapy
• have or have had too much calcium in your blood
• have any other medical conditions
• are pregnant or thinking about becoming pregnant. It is not known if Bonsity will harm your unborn baby.
• are breastfeeding or plan to breastfeed. You should not breastfeed while taking Bonsity.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider needs this information to help keep you from taking Bonsity with other medicines that may harm you.

Tell your doctor if you are pregnant or planning to become pregnant.

There are no well-done studies that have been done in humans with Bonsity. In animal studies, pregnant animals were given large doses of Bonsity and some showed medical issues related to this medication including an increased incidence of skeletal deviations or variations (interrupted rib, extra vertebra or rib). Discuss the potential risks versus benefits of using Bonsity during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Bonsity crosses into human milk. Because many medications can cross into human milk and because the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Bonsity.

• Inject Bonsity one time each day in your thigh or abdomen (lower stomach area). Talk to a healthcare provider about how to rotate injection sites.
• Before you try to inject Bonsity yourself, a healthcare provider should teach you how to use the Bonsity delivery device to give your injection the right way.
• You can take Bonsity with or without food or drink.
• The Bonsity delivery device has enough medicine for 28 days. It is set to give a 20-microgram dose of medicine each day. Do not inject all the medicine in the Bonsity delivery device at any one time.
• Do not transfer the medicine from the Bonsity delivery device to a syringe. This can result in taking the wrong dose of Bonsity. If you do not have pen needles to use with your Bonsity delivery device, talk with your healthcare provider.
• Bonsity should look clear and colorless. Do not use Bonsity if it has particles in it, or if it is cloudy or colored.
• Inject Bonsity right away after you take the delivery device out of the refrigerator.
• After each use, safely remove the needle, recap the delivery device, and put it back in the refrigerator right away.
• You can take Bonsity at any time of the day. To help you remember to take Bonsity, take it at about the same time each day.
• If you forget or cannot take Bonsity at your usual time, take it as soon as you can on that day. Do not take more than one injection in the same day.
• If you take more Bonsity than prescribed, call your healthcare provider. If you take too much Bonsity, you may have nausea, vomiting, weakness, or dizziness.
• Follow your healthcare provider's instructions about other ways you can help your osteoporosis, such as exercise, diet, and reducing or stopping your use of tobacco and alcohol. If your healthcare provider recommends calcium and vitamin D supplements, you can take them at the same time you take Bonsity.

Take this medication exactly as prescibed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose is 20 mcg subcutaneously (just under the skin) once a day.

If you take too much Bonsity, call your healthcare provider or local poison control center, or seek emergency medical attention right away.

• Keep your Bonsity delivery device in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze the Bonsity delivery device. Do not use Bonsity if it has been frozen.
• Do not use Bonsity after the expiration date printed on the delivery device and packaging.
• Throw away the Bonsity delivery device after 28 days even if it has medicine in it (see the User Manual).
• Keep Bonsity and all medicines out of the reach of children.

WARNING: POTENTIAL RISK OF OSTEOSARCOMA

In male and female rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration. The effect was observed at systemic exposures to teriparatide ranging from 3 to 60 times the exposure in humans given a 20 mcg dose. Because of the uncertain relevance of the rat osteosarcoma finding to humans, prescribe BONSITY only for patients for whom the potential benefits are considered to outweigh the potential risk. BONSITY should not be prescribed for patients who are at increased baseline risk for osteosarcoma (including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult patients with open epiphyses, or prior external beam or implant radiation therapy involving the skeleton).