Tymlos

Tymlos injection is a prescription medicine used to treat osteoporosis in men and postmenopausal women who are at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapies. In postmenopausal women, Tymlos reduces the risk of spinal (vertebral) and non-spinal (nonvertebral) fractures. In men, Tymlos is approved to increase bone density. Tymlos injection helps to stimulate the natural bone-rebuilding process to increase bone mineral density and bone strength, which may prevent fractures.

Tymlos is a man-made (synthetic) form of parathyroid hormone-related peptide (PTHrP), a substance found naturally in the body that influences bone remodeling. Tymlos (abaloparatide) works by acting on specific receptors (PTH1 receptor) that stimulate osteoblasts (cells that lay down new bone), which increases bone mass (bone mineral density).

Tymlos is given as an injection under the skin (subcutaneous injection) daily using the Tymlos pen (autoinjector).

Tymlos FDA approved to be used to treat:

• postmenopausal women with osteoporosis at high risk for fracture.
• men with osteoporosis to help increase bone density in those at high risk for fracture

Tymlos injection is used for patients who are at high risk for fracture (defined in the label as a history of an osteoporotic fracture, or multiple risk factors for fracture) or patients who have failed or are intolerant to other available osteoporosis therapies.

Patients should take calcium and vitamin D supplements if their dietary intake is inadequate.

The safety and effectiveness of Tymlos have not been studied beyond 2 years of treatment. Using Tymlos for more than 2 years (24 months) during a lifetime is not recommended.

Tymlos is injected under the skin, usually once per day using the Tymlos pen. Each Tymlos pen contains 30 doses.

Injections should be given in the lower stomach area (abdomen). Avoid the 2- inch area around your belly button (navel). Use a different place each time you give an injection. Do not inject into the same place two times in a row. Do not inject into a vein or into muscle.

Use Tymlos injection at the same time each day with or without food or drink.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it. Do not use it.

Use only the injection pen provided with Tymlos. Do not transfer the medicine to a syringe or other injection device or you could get an overdose.

Never share a Tymlos injection pen, cartridge, or syringe even if you changed the needle. Sharing these devices can pass infections from person to person.

Tymlos injection can cause dizziness. Always give your injection at a time and place where you can sit or lie down for a short time, especially for your first several doses.

General information

A healthcare provider may teach you how to properly use the medication by yourself. Do not inject Tymlos yourself until you or your caregiver have been trained on how to use the pen.

Read and carefully follow these Instructions for Use which also contain diagrams. Ask your doctor or pharmacist if you don't understand all the instructions.

Use Tymlos exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Your doctor may recommend calcium and vitamin D supplements if you are not getting enough from your diet. Follow your doctor's instructions closely.

You may need medical tests during and after treatment. Your doctor may do blood and urine tests during treatment, and may ask you to have a bone mineral density test after your treatment with Tymlos finishes.

Before first use, store the medication in the refrigerator.

After first use, store the medication for up to 30 days at room temperature.

Do not freeze or expose to heat.

Each prefilled injection pen contains enough abaloparatide for 30 separate injections. Throw the pen away after 30 days, even if there is still medicine left inside.

Serious allergic reactions. Serious allergic (hypersensitivity) reactions, including anaphylaxis, angioedema (swelling under the skin) and hives have been reported in people treated with parathyroid hormone analogs, including Tymlos. Stop using Tymlos and get medical help right away if you have symptoms of an allergic reaction. If you have a severe reaction, Tymlos should not be restarted

Bone cancer (osteosarcoma). Abaloparatide, the active ingredient in Tymlos, caused a dose-related increase in osteosarcoma in male and female rats. It is not known whether Tymlos will cause osteosarcoma in people. Osteosarcoma has been reported in people treated with a PTH analog after these medicines were marketed; however, an increased risk of osteosarcoma has not been seen in observational studies in humans. There is limited information on osteosarcoma risk beyond 2 years of treatment with Tymlos or another PTH analog. Tymlos should be avoided in people who already have a higher baseline risk of osteosarcoma, including those with:

• open growth plates (open epiphyses) — Tymlos is not approved for children
• bone diseases other than osteoporosis, including Paget's disease of the bone
• bone metastases or a history of bone (skeletal) cancers
• previous external beam or implant radiation therapy involving the bones
• inherited conditions that increase the risk of osteosarcoma.

Call your doctor at once if you have bone pain, unusual body aches, or a lump or swelling under your skin that is tender to touch, or pain anywhere in your body that does not go away.

Avoid smoking cigarettes or drinking alcohol. Smoking or heavy drinking can reduce your bone mineral density, making fractures more likely.

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our Tymlos Prices, Coupons, Copay Cards & Patient Assistance page for more information about the cost.

Tymlos copay card

You may pay as little as $0 out-of-pocket for a 30-day supply of Tymlos if you qualify for the Tymlos copay card (Tymlos coupon). The Copay card (Savings card) is available for patients with commercial or private insurance, who are over 18 years old with a valid prescription for this medicine.

It is not available for prescriptions covered by state or federal government-funded healthcare programs, such as Medicare (including Part D), Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, and Veterans Administration.

You should not use Tymlos injections if you have had a severe allergic reaction to the active ingredient abaloparatide, or any of the inactive ingredients. Reactions have included anaphylaxis, angioedema, difficulty breathing, and hives.

Tymlos injection is not for use in children or young adults whose bones are still growing. Its safety and effectiveness have not been established in anyone 18 years or younger.

To make sure Tymlos injections are safe for you, tell your doctor if you have ever had:

Abaloparatide has caused bone cancer (osteosarcoma) in rats, and Tymlos should be avoided if you already have a higher baseline risk of osteosarcoma — see Warnings above. Talk with your doctor about your own risk.

Tymlos is for use only in women who can no longer get pregnant; it is not indicated for use in women who can become pregnant. It is not known whether this medicine will harm an unborn baby. There are no data on Tymlos use in pregnant women, and animal reproduction studies have not been carried out. Tell your doctor if you think you may be pregnant.

It may not be safe to breastfeed while using this medicine. There is no information on whether abaloparatide passes into human milk, or on its effects on a breastfed baby or on milk production.

Common Tymlos side effects

Common Tymlos side effects in postmenopausal women are:

• Too much calcium in the urine, hypercalciuria 11%
• Dizziness 10%
• Nausea 8%
• Headache 8%
• Fast heart rate, palpitations 5%
• Feeling very tired, fatigue 3%
• Upper stomach (abdominal) pain 3%
• Spinning sensation, vertigo 2%
• Injection site reactions.

The common side effects in postmenopausal women occurred in 2% or more of Tymlos patients in the Study 003 clinical trial (NCT 01343004) which compared Tymlos (N=822) with placebo (N=820) over 18 months.

Common Tymlos side effects in men are:

• Injection site redness 13%
• Dizziness 9%
• Joint pain 7%
• Injection site swelling 7%
• Injection site pain 6%
• Bruising 3%
• Stomach bloating or distension 3%
• Diarrhea 3%
• Nausea 3%
• Stomach pain 2%
• Bone pain 2%

The common side effects in men occurred in 2% or more of Tymlos patients in Study 019 (NCT 03512262).

Serious Tymlos side effects

Get emergency medical help if you have signs of an allergic reaction to Tymlos: hives; difficulty breathing; swelling of your face, lips, tongue, or throat; swelling of your mouth; itching; rash; fast heartbeat; or fainting, dizziness or feeling lightheaded. Serious allergic reactions, including anaphylaxis and angioedema, have been reported with Tymlos and with other parathyroid hormone (PTH) analogs. Stop taking Tymlos and get medical help right away if these occur

Tymlos may cause other serious side effects, call your doctor at once if you have:

• a light-headed feeling, like you might pass out (may occur within 4 hours after injection);
• bone pain;
• unusual body aches;
• a new or worsening lump or swelling under your skin, especially if it is tender to the touch
• pounding heartbeats or fluttering in your chest;
• high calcium levels - confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss, muscle weakness, or
• signs of a kidney stone - severe pain in your side or lower back, blood in your urine, painful or difficult urination.

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 the FDA at 1-800-FDA-1088.

Usual Adult Tymlos Dose for Osteoporosis: 80 mcg subcutaneously once a dayGeneral dosing information:

Dosage Forms and Strength

Tymlos pen:

• 3120 mcg/1.56 ml (2000 mcg/ml) of abaloparatide.
• The prefilled pen delivers 30 daily doses of 80 mcg abaloparatide in 40 mcl.

Use the missed dose on the same day you remember it. Use your next dose at the regular time and stay on your once-daily schedule. Do not use 2 doses in one day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, dizziness, vomiting, rapid heartbeats, feeling light-headed, fainting, nausea, muscle weakness, low energy, and high blood calcium levels. If you take more Tymlos than prescribed, stop taking it and call your doctor right away.

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.

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.

No specific drug interaction studies have been carried out with Tymlos. In laboratory studies, abaloparatide did not inhibit or induce the CYP450 liver enzymes at therapeutic concentrations, and it is not a substrate of the kidney transporters OAT1, OAT3, OCT2, MATE1 or MATE2K.

Other drugs may interact with abaloparatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Not all possible drug interactions are listed here.

HCPs and patients often use the Tymlos Package Insert (PI) for more detailed information about this medicine. The Package Insert (prescribing information) contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Tymlos Prescribing Information (PI) or FDA label.

Active ingredient: abaloparatide

Inactive ingredients: glacial acetic acid, phenol, sodium acetate trihydrate, and water for injection.

Tymlos manufacturer Radius Health, Inc., 22 Boston Wharf Road, 7th Floor, Boston, MA 02210