Teriparatide DR.Reddys 20 micrograms/80 Microliters solution for injection in Pre-filled pen – patient leaflet, side effects, dosage

1. What Teriparatide solution for injection in pre-filled pen is and what it is used for

Teriparatide solution for injection in pre-filled pen contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation. Teriparatide solution for injection in pre-filled pen is used to treat osteoporosis in adults. Osteoporosis is a disease that causes your bones to become thin and fragile. This disease is especially common in women after the menopause, but it can also occur in men. Osteoporosis is also common in patients receiving corticosteroids.

2. What you need to know before you use Teriparatide solution for injection in pre-filled pen

Do not use Teriparatide solution for injection in pre-filled pen

• if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from high calcium levels (pre-existing hypercalcaemia).
• if you suffer from serious kidney problems.
• if you have ever been diagnosed with bone cancer or other cancers that have spread (metastasised) to your bones.
• if you have certain bone diseases. If you have a bone disease, tell your doctor.
• if you have unexplained high levels of alkaline phosphatase in your blood, which means you might have Paget’s disease of bone (disease with abnormal bone changes). If you are not sure, ask your doctor.
• if you have had radiation therapy involving your bones.
• if you are pregnant or breast-feeding.

Warnings and precautions

Teriparatide may cause an increase in the amount of calcium in your blood or urine.

Talk to your doctor or pharmacist before or while using Teriparatide solution for injection in pre-filled pen:

• if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.
• if you suffer from kidney stones or have a history of kidney stones.
• if you suffer from kidney problems (moderate renal impairment). Some patients get dizzy or get a fast heartbeat after the first few doses. For the first doses, inject teriparatide where you can sit or lie down right away if you get dizzy.

The recommended treatment time of 24 months should not be exceeded. Teriparatide solution for injection in pre-filled pen should not be used in growing adults.

Children and adolescents

Teriparatide solution for injection in pre-filled pen - should not be used in children and adolescents (less than 18 years).

Other medicines and Teriparatide solution for injection in pre-filled pen Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, because occasionally they may interact (e.g. digoxin/digitalis, a medicine used to treat heart disease).

Pregnancy and breast-feeding

Do not use Teriparatide solution for injection in pre-filled pen if you are pregnant or breast-feeding. If you are a woman of child-bearing potential, you should use effective methods of contraception during use of Teriparatide solution for injection in pre-filled pen. If you become pregnant, teriparatide should be discontinued. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines

Some patients may feel dizzy after injecting teriparatide. If you feel dizzy you should not drive or use machines until you feel better. Teriparatide solution for injection in pre-filled pen contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose that is to say essentially “sodiumfree”.

3. How to use Teriparatide solution for injection in pre-filled pen

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

The recommended dose is 20 micrograms given once daily by injection under the skin (subcutaneous injection) in the thigh or abdomen. To help you remember to take your medicine, inject it at about the same time each day.

Inject Teriparatide solution for injection in pre-filled pen each day for as long as your doctor prescribes it for you. The total duration of treatment with teriparatide should not exceed 24 months. You should not receive more than one treatment course of 24 months over your lifetime.

Teriparatide solution for injection in pre-filled pen can be injected at meal times.

Read the user manual booklet, which is included in the carton for instructions on how to use the Teriparatide solution for injection in pre-filled pen pen.

Injection needles are not included with the pen. The device can be used with insulin pen injection needles of 31G.

You should take your teriparatide injection shortly after you take the pen out of the refrigerator as described in the user manual. Put the pen back into the refrigerator immediately after you have used it. Use a new injection needle for each injection and dispose of it after each use. Never store your pen with the needle attached. Never share your teriparatide pen with others.

Your doctor may advise you to take teriparatide with calcium and vitamin D. Your doctor will tell you how much you should take each day. Teriparatide solution for injection in pre-filled pen can be given with or without food.

Package leaflet: Information for the user Teriparatide Dr. Reddy's 20 micrograms/80 microliters

solution for injection in pre-filled pen

teriparatide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you. — Keep this leaflet. You may need to read it again.

— If you have any further questions, ask your doctor or pharmacist. — This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. — If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. x

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Version No: v2

Submission

Brand: Dr. Reddy’s

Country: UK

Product Name: Teriparatide

Strength: 20 micrograms/80 microliters

Form: Solution for Injection

Component: Leaflet

Pack Size: N/A

Date Created: 10 May 2024

Date Modified: 13 Feb 2025

Project: CC1000153888

Previous DR No: DR001749

Previous Material

Number:

1200008239 & 106117

Commercial

DR No: DR00xxxx

Material Code: xxxxxx & 120000xxxx

Third Party

Material Code:

N/A

Process Black

Dr. Reddy’s Laboratories (UK) Ltd,

410 Cambridge Science Park, Milton Road, Cambridge,

CB4 0PE, United Kingdom

Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only. If you use more Teriparatide solution for injection in pre-filled pen than you should

If, by mistake, you have used more teriparatide than you should, contact your doctor or pharmacist.

The effects of overdose that might be expected include nausea, vomiting, dizziness, and headache.

If you forget or cannot take Teriparatide solution for injection in pre-filled pen at your usual time, take it as soon as possible on that day. Do not take a double dose to make up for a forgotten dose. Do not take more than one injection in the same day. Do not try to make up for a missed dose.

If you stop taking Teriparatide solution for injection in pre-filled pen If you are considering stopping teriparatide treatment, please discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with teriparatide.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

The most common side effects are pain in limb (frequency is very common, may affect more than 1 in 10 people) and feeling sick, headache and dizziness (frequency is common). If you become dizzy (light-headed) after your injection, you should sit or lie down until you feel better. If you do not feel better, you should call a doctor before you continue treatment. Cases of fainting have been reported in association with teriparatide use.

If you experience discomfort such as redness of the skin, pain, swelling, itching, bruising or minor bleeding around the area of the injection (frequency is common), this should clear up in a few days or weeks. Otherwise tell your doctor as soon as possible. Some patients may have experienced allergic reactions soon after injection, consisting of breathlessness, swelling of the face, rash and chest pain (frequency is rare). In rare cases, serious and potentially life-threatening allergic reactions including anaphylaxis can occur. Other side effects include:

Common: may affect up to 1 in 10 people

• increase in blood cholesterol levels
• depression
• neuralgic pain in the leg
• feeling faint
• irregular heart beats
• breathlessness
• increased sweating
• muscle cramps
• loss of energy
• tiredness
• chest pain
• low blood pressure
• heartburn (painful or burning sensation just below the breast bone)
• being sick(vomiting)
• a hernia of the tube that carries food to your stomach
• low haemoglobin or red blood cell count (anaemia) Uncommon: may affect up to 1 in 100 people
• increased heart rate
• abnormal heart sound
• shortness of breath
• haemorrhoids (piles)
• accidental loss or leakage of urine
• increased need to pass water
• weight increase
• kidney stones

• pain in the muscles and pain in the joints. Some patients have experienced severe back cramps or pain which lead to hospitalisation.

  • increase in blood calcium level
  • increase in blood uric acid level
  • increase in an enzyme called alkaline phosphatase.

Rare: may affect up to 1 in 1,000 people

• reduced kidney function, including renal failure
• swelling, mainly in the hands, feet and legs.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Teriparatide solution for injection in pre-filled pen

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and pen after EXP. The expiry date refers to the last day of that month.

Teriparatide solution for injection in pre-filled pen should be stored in a refrigerator (2°C to 8°C) at all times. You can use Teriparatide solution for injection in pre-filled pen for up to 28 days after the first injection, as long as the pen is stored in a refrigerator (2°C to 8°C). Do not freeze Teriparatide solution for injection in pre-filled pen. Avoid placing the pens close to the ice compartment of the refrigerator to prevent freezing. Do not use Teriparatide solution for injection in pre-filled pen if it is, or has been, frozen.

Each pen should be properly disposed of after 28 days, even if it is not completely empty.

Teriparatide solution for injection in pre-filled pen contains a clear and colourless solution. Do not use Teriparatide solution for injection in pre-filled pen if solid particles appear or if the solution is cloudy or coloured.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use These measures will help to protect the environment.

6. Contents of the pack and other information

What Teriparatide solution for injection in pre-filled pen contains — The active substance is teriparatide. Each millilitre of the solution for injection contains 250 micrograms of teriparatide. — The other ingredients are acetic acid, glacial, sodium acetate, mannitol, metacresol, and water for injections. In addition, hydrochloric acid and/or sodium hydroxide solution may have been added for pH adjustment.

What Teriparatide solution for injection in pre-filled pen looks like and contents of the pack

Teriparatide solution for injection in pre-filled pen is a colourless and clear solution. It is supplied in a cartridge contained in a pre-filled disposable pen. Each pen contains 2.4 mL of solution enough for 28 doses. The pens are available in cartons containing one or three pens. Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer Dr. Reddy’s Laboratories UK Ltd.

410 Cambridge Science Park

Milton Road

Cambridge

CB4 0PE

UK

This leaflet was last revised in February 2025. ^xxxxxx

120000xxxx

PEN USER MANUAL

Instructions for use

Teriparatide Dr. Reddy’s 20 micrograms (µg)/ 80 microlitres solution for injection, in pre-filled pen

Before you use your new pen, please read the section Instructions for use completely. Follow the directions carefully when using the pen. Also read the package leaflet provided.

Do not share your pen or your needles as this may risk transmission of infectious agents.

Your pen contains 28 days of medicine.

Teriparatide Parts*

* Needles not included.

The device can be used with insulin pen injection needles. Ask your doctor or pharmacist which needle gauge and length are best for you.

Always wash your hands before every injection. Prepare the injection site as directed by your doctor or pharmacist.

1

Pull off

grey cap

2

Attach new

needle

3

Set

dose

4

Clean the

administration

area with an

alcohol swab

and inject dose

5

Confirm

the dose

6

Remove needle

Pull off paper tab.

Pull out black

injection button

until it stops.

If you cannot pull

out the black

injection button -

see Troubleshooting,

Problem E, on back

page.

Gently hold a fold of skin on your thigh or

abdomen and insert needle straight into skin.

The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.

Unscrew the needle all the way by giving the large needle cover 3 to 5 complete turns.

Put large needle cover

on needle.

Pull off needle and throw away as directed by your doctor or pharmacist.

Push grey cap back on. Place the pen in the refrigerator immediately after use.

Push in black injection button until it stops. Hold it in and count to 5 s-l-o-w-l-y. Then pull the needle from skin. Check to make sure red stripe shows.

Pull off small needle protector and throw away.

Push needle straight onto medicine cartridge

Screw the needle until firmly attached

Pull off large needle cover and save it.

After completing the injection:

Once the needle is removed from the skin, check to make sure the black injection button is all the way in. If the white shaft does not show, you have completed the injection steps correctly.

You should NOT see any of the white shaft. If you do and have already injected, do not inject yourself a second time on the same day. Instead, you MUST reset the pen

(see Troubleshooting Problem A).

IMPORTANT

For more information, or if you have any questions, turn to the back of this page.

Teriparatide Dr. Reddy’s 20 micrograms/80 microliters ^injection

SC

Store in a refrigerator 2.4 mL

Code No.: KR/DRUGS/KTK/28/0457/2020

LOT:

EXP:

Troubleshooting

PROBLEM SOLUTION

The white shaft is still showing after I push in the black

injection button.

How do I reset my pen?

A.

How can I tell if my pen works?

B.

I see an air bubble in my pen.

C.

I cannot get the needle off.

D.

What should I do if I cannot pull out the black injection button?

E.

To reset the pen, follow the steps below.

1. 1) If you have already injected, DO NOT inject yourself a second time on the same day.
2. 2) Remove the needle.
3. 3) Attach a new needle, pull off the large needle cover and save it.
4. 4) Pull out the black injection button until it stops. Check to make sure the red stripe shows.
5. 5) Pull off the small needle protector and throw away.
6. 6) Point the needle down into an empty container. Push in the black injection button until it stops. Hold it in and count to 5 s-l-ow-l-y. You may see a small stream or drop of fluid. When you have finished, the black injection button should be all the way in.
7. 7) If you still see the white shaft showing, please contact your doctor or pharmacist.
8. 8.

   Put the large needle cover on needle. Unscrew the needle all the way by giving the needle cover 3 to 5 complete turns. Pull off needle cover and throw away as directed by your doctor or pharmacist. Push the grey cap back on, and place the pen in the refrigerator.

   You can prevent this problem by always using a NEW needle for each injection, and by pushing the black injection button all the way in and counting to 5 s-l-o-w-l-y.

The pen is designed to inject the full dose every time it is used according to the directions in the section Instructions for Use. The black injection button will be all the way in to show that the full dose has been injected from the pen. Remember to use a new needle every time you inject to be sure your pen will work properly.

A small air bubble will not affect your dose nor will it harm you. You can continue to take your dose as usual.

1. 1) Put the large needle cover on the needle.
2. 2) Use the large needle cover to unscrew the needle.
3. 3) Unscrew the needle all the way by giving the large needle cover 3 to 5 complete turns.
4. 4) If you still cannot get the needle off, ask someone to help you.

Change to a new pen to take your dose as directed by your doctor or pharmacist.

This indicates that you have now used all the medicine that can be injected accurately even though you may still see some medicine left in the cartridge.

Cleaning Your pen

• Wipe the outside of the pen with a damp cloth.
• Do not place the pen in water, or wash or clean it with any liquid.

Storing Your pen

• Refrigerate the pen immediately after every use. Read and follow the instructions in the Information for the Patient leaflet on how to store your pen.
• Do not store the pen with a needle attached as this may cause air bubbles to form in the cartridge.
• Store the pen with the grey cap on.
• Never store the pen in the freezer.
• If the medicine has been frozen, throw the device away and use a new pen.
• If the pen has been left out of the refrigerator, do not throw the pen away. Place the pen back in the refrigerator and contact your doctor or pharmacist.

Disposal of Pen Needles and Pen Device

• Before disposing of the pen device, be sure to remove the pen needle.
• Put used needles in a sharps container or a hard plastic container with a secure lid. Do not throw needles directly into your household waste.
• Do not recycle the filled sharps container.
• Ask your healthcare professional about options to dispose of the pen and the sharps container properly.
• The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.

• Dispose of the device 28 days after first use.

  Manufactured by

  Dr. Reddy’s Laboratories UK Ltd.

  410 Cambridge Science Park

  Milton Road

  Cambridge

  CB4 0PE

  UK

  This user manual was last revised in February 2025.

  Cleaning and Storage Other Important Notes

  Disposal of Pen Needles and Device

  • The pen contains 28 days of medicine.
  • Do not transfer the medicine into a syringe.
  • Write down your first injection date on a calendar.
  • Read and follow the instructions in the Information for the Patient leaflet for using the product.
  • Check the pen label to make sure you have the correct medicine, and that it has not expired.

  • Contact your doctor or pharmacist if you notice any of the following:-

    • The pen appears damaged
    • The solution is NOT clear, colourless and free of particles
  • Use a new needle for each injection.
  • During injection, you may hear one or more clicks – this is a normal device operation.
  • The pen is not recommended for use by the blind or visually impaired persons without the assistance of a person trained in the proper use of the device.

  • Keep the pen out of the sight and reach of children.

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    120000xxxx xxxxxx