Active ingredient: Abaloparatide

Tymlos is a prescription medicine used to:

·         Decrease the chance of having a fracture of the spine and other bones in postmenopausal women with thinning and weakening bones (osteoporosis).

·         Treat osteoporosis in postmenopausal women who are at high risk for bone fracture. It is not known if Tymlos is safe and effective for children 18 years and younger. It is not recommended that people use Tymlos for more than 2 years during their lifetime. Tymlos should not be used in children and young adults whose bones are still growing.

Contraindications:

Do not use Tymlos if you are allergic to Abaloparatide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions:

Before you use Tymlos, talk to your doctor or pharmacist, or nurse including if you:

·         have Paget’s disease of the bone or other bone disease.

·         have or have had cancer in your bones.

·         have had radiation therapy involving your bones.

·         have or have had too much calcium in your blood.

·         have or have had too much of an enzyme called alkaline phosphatase in your blood.

·         have or have had an increase in your parathyroid hormone (hyperparathyroidism).

·         will have trouble injecting yourself with the Tymlos pen and do not have someone who can help you.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist each time you get a new medicine.

Pregnancy and breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

·         Tymlos is not for pregnant women.

·         are breastfeeding or plan to breastfeed. It is not known if Tymlos passes into your breast milk. You and your healthcare providers should decide if you will take Tymlos or breastfeed. You should not do both.

Children and adolescents

It is not known if Tymlos is safe and effective for children 18 years and younger. Tymlos should not be used in children and young adults whose bones are still growing.

Geriatric Use

Of the total number of patients in the postmenopausal osteoporosis clinical studies of Tymlos, 82% were age 65 years and over, and 19% were age 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment

No dosage adjustment is required for patients with mild, moderate, or severe renal impairment. A study of a single dose of Tymlos 80 mcg given subcutaneously was conducted in subjects with normal renal function or mild, moderate, or severe renal impairment. The maximal concentration (Cmax) and area under the concentration-time curve (AUC) of Abaloparatide increased 1.4- and 2.1-fold, respectively, in subjects with severe renal impairment, compared to subjects with normal renal function. Patients with severe renal impairment may have increased Abaloparatide exposure that may increase the risk of adverse reactions; therefore, monitor for adverse reactions

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dosage is

·         The recommended dosage of Tymlos is 80 mcg subcutaneously once daily.

·         Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.

Method of administration

·         Read the detailed Instructions for Use provided with your medicine.

·         Use Tymlos exactly as your healthcare provider tells you to use it.

·         Do not try to inject Tymlos yourself until you or your caregiver receive training from a healthcare provider on the right way to use the Tymlos pen.

·         You should receive your first several injections of Tymlos where you can sit or lie down if necessary until you know how it affects you.

·         Inject Tymlos 1 time each day into your lower stomach area (abdomen) just under your skin (subcutaneous). Avoid giving your injection within the 2-inch area around your belly button (navel).

·         Talk to your healthcare provider about how to change (rotate) your injection site for each injection. Do not give Tymlos in your veins (intravenously) or deep into your muscles (intramuscularly).

·         You can take Tymlos with or without food or drink.

·         Take Tymlos at about the same time each day.

·         The Tymlos pen has enough medicine for 30 days. It is set to give 1 dose of medicine with each injection. Do not take more than 1 injection in the same day.

·         Do not transfer the medicine from the Tymlos pen to a syringe. This can cause you to use the wrong dose of Tymlos. If you do not have pen needles to use with your Tymlos pen, talk with your healthcare provider.

·         Do not share your Tymlos pen or pen needles with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

·         Tymlos should look clear and colorless. Do not use Tymlos if it has particles in it, or if it is cloudy or colored.

·         Your healthcare provider may do blood and urine tests during your treatment with Tymlos.

·         Your healthcare provider may ask you to have a bone mineral density test after your treatment with Tymlos.

·         If your healthcare provider recommends calcium and vitamin D supplements, you can take them while using Tymlos.

INSTRUCTIONS FOR USE

Read and follow this Instructions for Use so that you inject Tymlos pen the right way. Call your healthcare provider if you have any questions about the right way to inject the Tymlos pen.

Important information about your Tymlos pen

·         Do not try to inject Tymlos yourself until you or your caregiver receive training from a healthcare provider on the right way to use Tymlos pen.

·         Do not share your Tymlos pen or pen needles with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

·         Each Tymlos pen is a prefilled pen containing 30 doses of Tymlos. Each dose will contain 80 mcg of Tymlos. You do not have to measure your dose. The pen measures each dose of Tymlos for you.

·         Use a new pen needle for each injection. Keep the cap on the Tymlos pen when not using the pen.

·         Before using the pen always check the label to be sure it is your Tymlos pen.

·         Do not use your Tymlos pen if it looks damaged. If you drop your Tymlos pen or it becomes damaged, call your healthcare provider or pharmacist.

·         To clean your Tymlos pen, wipe the outside of the pen with a clean, damp cloth, if needed.

·         The Tymlos pen is not recommended for use by the blind or visually impaired without the help of a person trained in the right way to use the pen.

Pen needles to use with your Tymlos pen

·         Pen needles are not included with your Tymlos pen. You will need a prescription from your healthcare provider to get pen needles from your pharmacy.

·         The correct needles to use with your Tymlos pen are 5 to 8 mm, 31-gauge needles. If you are not sure what type of needle to use, ask your healthcare provider or pharmacist.

Supplies you will need for each injection using your Tymlos pen

·         1 Tymlos pen

·         1 pen needle

·         1 alcohol swab

·         1 cotton ball or gauze pad

·         1 sharps disposal container for pen needles and Tymlos pens.

Injection of Tymlos

 Step 1:

Check Tymlos pen Wash your hands.

Check the expiry date (EXP) on the pen.

If the expiry date has passed, do not use the pen. Write down the date for Day 1 to ensure that you do not use the pen for more than 30 consecutive days.

Remove the cap from your pen.

Check the Tymlos cartridge. The liquid should be clear, colorless and free from particles, otherwise do not use it. You may notice small air bubbles in the liquid. It's normal.

Step 2

Attach the needle to your Tymlos pen

Remove the protective film from the new needle.

The needle with its cap must be inserted straight into the pen and screwed in until the stopper. Make sure the needle is straight, so it doesn't bend when inserting. the pen will not work if the needle is not attached correctly. Do not overtighten, as the needle may be difficult to remove.

Save the outer needle cap and use it to remove the needle after the injection is finished.

Gently remove the inner needle cap and throw it away.

Step 3

Day 1 only – Testing a Tymlos pen before giving the first injection

Your pen contains medicinal substance for 30 days, in addition to a small amount allowing each pen to be tested once, to ensure that it is working properly.

Warning: if you test your pen before each injection, it will quickly run out of substance medicated. Therefore, do step 3 only on day 1, before your first injection.

From day 2 to day 30, do not test the pen again, go directly to step 4 to set the dose of your injection.

Before injecting, holding the pen as shown, turn the dose selector all the way to the stopper.

You will see the “•80” lined up in the dose display window.

Hold the pen with the needle pointing up.

Fully depress the green injection button.

You should see liquid, in the form of a drop or a jet, being expelled from the tip of the needle

You should see the “•0” lined up in the dose display window.

Step 4

Set the dose on your Tymlos pen

Before injecting, turn the white knob of your pen until it stops and the graduation “•80” lined up in the dose display window. Your pen is now ready for injection.

Step 5

Selecting and cleaning your injection site

Injections should be administered in the lower abdomen, as shown in the shaded area. Avoid the 5 cm zone around the navel.

Select a different injection site on your abdomen each day. Perform the injection of Tymlos only on clean skin. Do not inject the product into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with scars or stretch marks.

Clean the injection site with an alcohol swab and let it dry. Do not touch, fan, or blow on the injection site after cleaning it. Note: Your doctor, nurse or pharmacist may recommend that you pinch the skin at the injection site.

Once the needle has penetrated your skin, the pinch can be released.

Step 6

Perform the injection using your Tymlos pen

Insert the needle straight into your skin.

Press and HOLD the green button until ALL steps are completed below

·         The graduation “•0” appears

·         Count to 10 to make sure you get the full dose

·         Remove the pen from your skin THEN release your finger from the button.

Do not press the green button if there is no needle attached to the pen.

Note: Do not move the pen after inserting it.

Slowly pull the pen needle out of the injection site, making sure it stays straight.

A slight bleeding may occur, this is normal. Do not rub the injection site. If a slight bleeding occurs, press the injection site with a cotton ball or swab. gauze, if needed. You can also cover the area with a small adhesive bandage.

Step 7

Remove the needle from the pen

Caution: To avoid needlestick injuries, follow this step carefully.

Carefully put the outer cap back on the needle. Then carefully press the outer needle cap until it clicks and is securely attached.

Unscrew the needle with its cap (like a bottle cap). To unscrew the needle with its cap, press the lower part of the cap against the needle, then twist it 8 or more times before pulling it gently until the needle comes off.

Note: Do not press on the outer needle cap when unscrewing the needle.

Note: As you unscrew the needle, a growing space should form between the cap outer needle and pen.

Step 8

After your injection

Put the pen cap firmly back on the Tymlos pen. Leave the cap on your pen between injections.

How should I throw away (dispose) of the pen needles and Tymlos pens?

Throw away (dispose of) your Tymlos pen, in a cleared sharps disposal container or puncture resistant container, 30 days after first opening it even if it still contains unused medicine.

Put your used pen needles in a cleared sharps disposal container right away after use. Do not throw away (dispose of) your used sharps disposal container in your household trash.

If you do not have a cleared sharps disposal container, you may use a household container that is:

- Made of a heavy-duty plastic.

- Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out.

- Upright and stable during use.

- Leak-resistant, and properly labeled to warn of hazardous waste inside the container.

General information about the safe and effective use of Tymlos.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Tymlos for a condition for which it was not prescribed. Do not give Tymlos to other people, even if they have the same condition you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Tymlos that is written for health professionals.

Duration of treatment

You should not use Tymlos for more than 2 years over your lifetime.

If you use more Tymlos than you should

If you take more Tymlos than prescribed you may have symptoms such as muscle weakness, low energy, headache, nausea, dizziness (especially when getting up after sitting for a while), and a faster heartbeat. Stop taking TYMLOS and call your healthcare provider right away.

If you forget to use Tymlos

If you forget or cannot take Tymlos at your usual time, take it as soon as you can on that day.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tymlos may cause serious side effects including:

·         Possible bone cancer (osteosarcoma). During animal drug testing, Tymlos caused some rats to develop bone cancer called osteosarcoma. It is not known if people who take Tymlos will have a higher chance of getting osteosarcoma. So Tell your healthcare provider right away if you have pain in your bones, pain in any areas of your body that does not go away, or any new or unusual lumps or swelling under your skin that is tender to touch.

·         Decrease in blood pressure when you change positions. Some people may feel dizzy, have a faster heartbeat, or feel lightheaded soon after the Tymlos injection is given. These symptoms generally go away within a few hours. Take your injections of Tymlos 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 Tymlos and call your healthcare provider.

·         Increased blood calcium (hypercalcemia). Tymlos can cause some people to have a higher blood calcium level than normal.

Your healthcare provider may check your blood calcium before you start and during your treatment with TYMLOS. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.

·         Increased urine calcium (hypercalciuria). Tymlos can cause some people to have higher levels of calcium in their urine than normal. Increased calcium may also cause you to develop kidney stones (urolithiasis) in your kidneys, bladder, or urinary tract.

Tell your healthcare provider right away if you get any symptoms of kidney stones which may include pain in your lower back or lower stomach area, pain when you urinate, or blood in your urine.

The most common side effects of Tymlos include:

·         Dizziness

·         Feeling tired (fatigue)

·         Nausea

·         upper stomach pain

·         Headache

·         Spinning feeling (vertigo)

·         Fast heartbeat

These are not all the possible side effects of Tymlos. Call your doctor for medical advice about side effects. You may report side effects to your healthcare professional.

Reporting of side effects

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, health care provider or pharmacist

·         Before first use, store Tymlos pens in the refrigerator between (2°C to 8°C).

·         Do not store pens with the needle attached.

·         After first use, continue to store TYMLOS in refrigerator between (2°C to 8°C).

·         Do not freeze the Tymlos pen or expose it to heat.

·         Do not use Tymlos after the expiration date printed on the pen and packaging.

·         Throw away the Tymlos pen after 30 days of use even if some medicine is left in the pen (see “Instructions for Use”).

·         Write down the date of your first use of Tymlos here: _______/_______/_______.

·         Keep Tymlos and all medicines out of the reach of children.