Tymlos

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• bone pain;
• unusual body aches;
• a new or worsening lump or swelling under your skin;
• pounding heartbeats or fluttering in your chest;
• high levels of calcium in your blood--nausea, vomiting, constipation, weakness, tired feeling; or
• symptoms of a kidney stone--severe pain in your side or lower back, blood in your urine, painful urination.

Common side effects may include:

• dizziness, spinning sensation;
• headache;
• fast heart rate;
• nausea, upper stomach pain; or
• feeling very tired.

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.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Other drugs may interact with abaloparatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

In animal studies, abaloparatide caused bone cancer. It is not known whether this medicine causes bone cancer in humans. Ask your doctor about your risk.

Call your doctor at once if you have bone pain, unusual body aches, or a lump or swelling under your skin.

Abaloparatide should not be used for longer than 2 years total.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• bone pain;

• unusual body aches;

• a new or worsening lump or swelling under your skin;

• pounding heartbeats or fluttering in your chest;

• high levels of calcium in your blood--nausea, vomiting, constipation, weakness, tired feeling; or

• symptoms of a kidney stone--severe pain in your side or lower back, blood in your urine, painful urination.

Common side effects may include:

• dizziness, spinning sensation;

• headache;

• fast heart rate;

• nausea, upper stomach pain; or

• feeling very tired.

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.

Abaloparatide has the following uses:

Abaloparatide is a PTHrP(1-34) analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.1

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.

Pediatric

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. However, use is not recommended in children with open epiphyses (bones are still growing) or genetic disorders.

Geriatric

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin in the belly area.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to use as you have been told by the doctor or read the package insert.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Move the site where you give the shot with each shot.
• Do not give into skin within 2 inches of the belly button.
• You may need to use this medicine (Tymlos) where you can sit or lie down right away if you get dizzy or feel like passing out. Talk with your doctor.
• Take this medicine at the same time of day.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it on the same day you missed the dose.
• If you do not think about the missed dose until the next day, skip the missed dose and go back to your normal time.
• Do not take more than 1 dose of this medicine (Tymlos) in the same day.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Upset stomach.
• Headache.
• Feeling tired or weak.
• Belly pain.
• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Recommended Dosage

• The recommended dosage of Tymlos is 80 mcg subcutaneously once daily.
• Cumulative use of Tymlos and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended [see Warnings and Precautions (5.1)].
• Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.

Administration Instructions

• Administer Tymlos as a subcutaneous injection into the periumbilical region of the abdomen. Rotate the site of the injection every day and administer at approximately the same time every day. Do not administer intravenously or intramuscularly.
• Administer the first several doses where the patient can sit or lie down if necessary, in case symptoms of orthostatic hypotension occur [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].
• Tymlos is a clear and colorless solution. Visually inspect Tymlos for particulate matter and discoloration prior to administration. Do not use if solid particles appear or if the solution is cloudy or colored.
• Provide appropriate training and instruction to patients and caregivers on the proper use of the Tymlos pen.

None.

Risk of Osteosarcoma

Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma in male and female rats after subcutaneous administration at exposures 4 to 28 times the human exposure at the clinical dose of 80 mcg [see Nonclinical Toxicology (13.1)]. It is unknown whether Tymlos will cause osteosarcoma in humans.

The use of Tymlos is not recommended in patients at increased risk of osteosarcoma including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, bone metastases or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, or prior external beam or implant radiation therapy involving the skeleton.

Cumulative use of Tymlos and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended.

Orthostatic Hypotension

Orthostatic hypotension may occur with Tymlos, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia or nausea, and may resolve by having the patient lie down. For the first several doses, Tymlos should be administered where the patient can sit or lie down if necessary [see Adverse Reactions (6.1)].

Hypercalcemia

Tymlos may cause hypercalcemia. Tymlos is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia [see Adverse Reactions (6.1)].

Hypercalciuria and Urolithiasis

Tymlos may cause hypercalciuria. It is unknown whether Tymlos may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered [see Adverse Reactions (6.1)].

Get emergency medical help if you have signs of an allergic reaction to Tymlos: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• bone pain;

• unusual body aches;

• a new or worsening lump or swelling under your skin;

• pounding heartbeats or fluttering in your chest;

• high levels of calcium in your blood - nausea, vomiting, constipation, weakness, tired feeling; or

• symptoms of a kidney stone - severe pain in your side or lower back, blood in your urine, painful urination.

Common Tymlos side effects may include:

• dizziness, spinning sensation;

• headache;

• fast heart rate;

• nausea, upper stomach pain; or

• feeling very tired.

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.