Abaloparatide (a-bal-oh-PAR-a-tide)

Treats osteoporosis in postmenopausal women and increases bone density in men with osteoporosis who are at high risk for bone fracture.

Brand Name(s):

Tymlos

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the stomach area.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You should receive the first several injections of this medicine while sitting or lying down if needed, until you know how this medicine affects you.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are tender, bruised, red, scaly, or hard.
• Use a new needle each time you inject your medicine. Do not store the prefilled pen with the needle attached.
• If the medicine in the prefilled syringe has changed color, or if you see particles in it, do not use it.
• You may take calcium and vitamin D supplements while you are using this medicine if needed. Follow your doctor's instructions about how to take these supplements.
• You should not use this medicine for more than 2 years during your lifetime.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Before first use: Store the medicine in the refrigerator. Do not freeze.
• After first use: Store the medicine at room temperature, away from heat and direct light for up to 30 days. Do not freeze.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, parathyroid disease, other bone disease (including Paget's disease of the bone), or a history of bone cancer. Tell your doctor if you had a bone radiation treatment.
• This medicine may increase your risk of having a bone cancer.
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Stand or sit up slowly if you feel lightheaded or dizzy.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dizziness, faintness, lightheadedness
• Fast, pounding, uneven heartbeat
• Nausea, vomiting
• Pain in the lower back, side, or stomach
• Red or dark brown urine, painful urination

If you notice these less serious side effects, talk with your doctor:

• Headache
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

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