Pronunciation:

a-bal-oh-PAR-a-tide

Brand Names:

• Tymlos

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Uses of This Medicine:

Abaloparatide is used to treat osteoporosis, and reduces the risk of having bone and spine fractures, in postmenopausal women with osteoporosis. It also increases bone density in men with osteoporosis who are at high risk for bone fracture, or who cannot use another osteoporosis treatment or other osteoporosis treatments did not work well.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of abaloparatide injection in the pediatric population. Safety and efficacy have not been established. Use is not recommended in children with open epiphyses (bones are still growing) or genetic disorders.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of abaloparatide injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone cancer, or history of or
• High levels of alkaline phosphatase (enzyme found in the bones) or
• Paget's disease of the bone—Use with caution. May increase the risk of developing bone cancer (osteosarcoma).

• Hypercalcemia (high calcium levels in the blood) or
• Hypercalciuria (high calcium levels in the urine) or
• Hyperparathyroidism (overactive parathyroid) or
• Kidney stones, history of—Use with caution. May cause side effects to become worse.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the stomach area.

This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Abaloparatide may sometimes be given at home to patients who do not need to be in a hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

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.

If you use abaloparatide at home, 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. This will help prevent skin problems. 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.

Use of this medicine for more than 2 years during your lifetime is not recommended.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (prefilled pen):
  • For osteoporosis in postmenopausal women:
    • Adults—80 micrograms (mcg) injected under the skin once a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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.

You might not use all of the medicine in each prefilled pen. Throw away any unused medicine that has been stored at room temperature after 30 days.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may increase your risk of having osteosarcoma (bone cancer). This is more likely to occur if you have a history of radiation treatment involving your bones. Check with your doctor right away if you have bone pain that does not go away or a new soft tissue mass that is tender to palpation.

This medicine may cause some people to become dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may increase levels of calcium in the blood and urine. High calcium in the urine may cause kidney stones. Call your doctor right away if you have blood in the urine, confusion, constipation, dry mouth, metallic taste, muscle weakness, nausea or vomiting, pain in the side, back, or stomach, or weight loss.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blood in the urine

constipation

depression

loss of appetite

loss of weight

muscle weakness

nausea or vomiting

pain in the bone, joint, back, arms, or legs

pain in the side, back, or stomach

thirst

unusual tiredness or weakness

Less common

Fast, irregular, pounding, or racing heartbeat or pulse

Incidence not known

Chest tightness

cough

difficulty swallowing

dizziness

fast heartbeat

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

trouble breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

difficulty in moving

headache

muscle pain or stiffness

Less common

Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position

feeling of constant movement of self or surroundings

sensation of spinning

unusual bruising

Incidence not known

Diarrhea

full or bloated feeling

general feeling of discomfort or illness

itching, rash

lack or loss of strength

muscle spasms of the leg and back

pressure in the stomach

swelling of the stomach area

trouble sleeping

unusual drowsiness, dullness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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