20 micrograms/80 microliters, solution
What Terrosa is and what it is used for
Terrosa contains the active substance teriparatide, which is used to make the skeleton stronger and reduce the risk of bone fractures by stimulating bone formation.
Terrosa is used to treat osteoporosis in adults. Osteoporosis is a disease that causes the bones in the body to become thin and fragile. The disease is particularly common in postmenopausal women, but can also occur in men. Osteoporosis is also common in patients receiving drugs called corticosteroids.
What you need to know before using Terrosa
Do not use Terrosa
- if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6).
- if you have high levels of calcium in your blood (previously confirmed hypercalcemia).
- if you have severe kidney problems.
- if you have had bone cancer or if another cancer has spread (metastasized) to the bone.
- if you have a certain type of bone disease. Tell your doctor if you have a bone disease.
- if you have unexplained high levels of alkaline phosphatase in your blood, which suggests that you may have Paget’s disease of bone (disease of abnormal breakdown and formation of bone). Consult your doctor if you are unsure.
- if you have received radiation therapy involving the bone structure.
- if you are pregnant or breastfeeding.
Warnings and precautions
Terrosa may increase the level of calcium in the blood or urine.
Talk to your doctor before or while using Terrosa:
- if you have persistent nausea, vomiting, constipation, low energy, or muscle weakness. It could be a sign that you have too much calcium in your blood.
- if you suffer from kidney stones or have had kidney stones in the past.
- if you suffer from kidney problems (moderately impaired kidney function).
Some patients become dizzy or have a fast heart rate after the first doses of Terrosa. Inject Terrosa where you can quickly sit or lie down if you feel dizzy.
The recommended treatment period of 24 months should not be exceeded.
Before inserting a cartridge into the Terrosa Pen, write down the manufacturing batch (lot) number of the cartridge and the date of the first injection on the outer carton of the cartridge. Leave this information if you need to report any side effects.
Terrosa should not be used in young adults who are still growing.
Children and young people
Terrosa should not be used in children or adolescents (under 18 years of age).
Other medicines and Terrosa
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
This is important because some medicines (eg digoxin/digitalis, used to treat heart disease) can affect the effect of teriparatide.
Pregnancy and breastfeeding
Do not use Terrosa if you are pregnant or breastfeeding. If you are a fertile woman, you must use a safe method of contraception during treatment with Terrosa. If you become pregnant during treatment with Terrosa, treatment with Terrosa must be stopped. Consult your doctor or pharmacist before using this medicine.
Driving ability and use of machinery
Some people may feel dizzy after injection with Terrosa. If you feel dizzy, do not drive or use tools or machines until you feel better.
Terrosa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is almost “sodium-free”.
How to use Terrosa
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 20 micrograms (equivalent to 80 microliters), which is injected under the skin in the thigh or abdomen, once a day.
Take your medicine at the same time each day to make it easier to remember to take it. Terrosa can be injected with meals. Inject Terrosa every day for as long as the doctor prescribes. The total duration of treatment with Terrosa should not exceed 24 months. You should not receive more than one 24-month course of treatment in your lifetime.
Your doctor may recommend that you take Terrosa with calcium and vitamin D. The doctor will tell you how much to take each day.
Terrosa can be taken with or without food.
Terrosa cartridges are designed to be used only with the reusable drug delivery system. Terrosa Pen for multiple doses and compatible pen needles. The pen and injection needles are not included in the package with Terrosa. To start treatment, however, an ampoule and pen package must be used, containing an inner package with a Terrosa cylinder ampoule and an inner package with a Terrosa Pen.
The pen can be used with ISO standard needles with a thickness of 29-31 gauge (diameter 0.25-0.33 mm) and length 5-12.7 mm for subcutaneous injection only.
Insert cartridge one into the pen before first use. It is very important to carefully follow the instructions for use that come with the pen for the correct use of this medicine.
Use a new injection needle for each injection to prevent contamination and dispose of the needle safely after use.
Never store the pen with the needle attached.
Never share a pen with other people.
Do not use your Terrosa Pen to inject other medicines (eg insulin ).
The pen is adapted to be used only with Terrosa.
Do not refill a cartridge.
Do not transfer the medicine to a syringe.
Inject Terrosa immediately after removing the pen with the cartridge inserted from the refrigerator, as described in the instructions for use. Place the pen with the cartridge inserted back into the refrigerator immediately after use. Do not remove the cartridge from the pen after each use. Keep it in the cartridge holder for the entire 28-day treatment period.
Prepare the pen for use
- Always read the instructions for use of the Terrosa Pen included in the box with the pen to ensure proper administration of Terrosa.
- Wash your hands before handling the cartridge or the pen.
- The expiry date on the cartridge label must always be checked before inserting the cartridge into the pen. Make sure the date when a new cartridge starts to be used is at least 28 days before the expiry date. Insert cartridge one into the pen before the first use according to the instructions for use of the pen. Enter the manufacturing batch (lot) number of each cartridge and the date of the first injection in a calendar. The date of the first injection should also be indicated on the outer carton of Terrosa (see the designated space on the carton: {First day of use:}).
- After inserting a new cartridge and before the first injection from cartridge one, the pen should be filled according to the instructions provided. Do not refill after the first dose.
Inject Terrosa
- Clean the skin where you will inject (thigh or abdomen) as directed by your doctor before injecting Terrosa.
- Gently grasp and squeeze the cleaned skin and insert the needle straight into the skin. Press and hold the button until the dose indicator has returned to the starting position.
- Leave the needle in the skin for six seconds after injection to make sure you got the full dose.
- Attach the outer needle cap to the pen needle and twist the cap counterclockwise to remove the pen needle. This keeps the remaining Terrosa sterile and does not leak from the pen. It also means that air does not return to the cartridge and that the needle does not clog.
- Put the cap on the pen. Leave cartridge one in the pen.
If you have used too much Terrosa
If you have accidentally used more Terrosa than you should, contact your doctor or pharmacist.
Expected effects of an overdose may include nausea, vomiting, dizziness, and headache.
If you forget to use Terrosa
If you forget an injection or cannot use the medicine at the usual time, inject as soon as possible on the same day. Do not use a double dose to make up for the missed dose. Do not take more than one injection on the same day even if you have missed a dose.
If you stop using Terrosa
If you are considering stopping Terrosa treatment, you should talk to your doctor. Your doctor will consult with you and decide how long you should continue with Terrosa.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are a pain in the arms and legs (very common, may affect more than 1 in 10 people). Other common side effects (which may affect up to 1 in 10 people) include nausea, headache, and dizziness. If you feel dizzy after injection one, sit or lie down until you feel better. If you do not improve, a doctor should be called before continuing the treatment. Cases of fainting have occurred following the use of teriparatide.
If you feel discomfort around the injection site such as redness, pain, swelling, itching, bruising or minor bleeding (which can be common), it should go away within a few days or weeks. Otherwise, a doctor should be contacted.
Patients have rarely (may affect up to 1 in 1,000 people) experienced allergic reactions, such as shortness of breath, facial swelling, rash, and chest pain. These reactions usually occur right after injection. In rare cases, serious and potentially life-threatening allergic reactions including anaphylaxis may occur.
Other side effects are:
Common (may affect up to 1 in 10 people):
- increased cholesterol levels in the blood
- Depression
- nerve pain in the legs
- feeling of weakness
- feeling dizzy
- irregular heartbeats
- shortness of breath
- increased sweating
- muscle cramps
- decreased energy
- fatigue
- chest pain
- low blood pressure
- heartburn (pain or burning sensation below the breastbone)
- vomiting
- hernia in the esophagus ( hiatal hernia )
- low hemoglobin or low red blood cell count ( anemia )
Uncommon (may affect up to 1 in 100 people):
- increased heart rate
- abnormal heart sound
- shortness of breath
- hemorrhoids
- urine leakage
- increased need to empty the bladder
- weight gain
- kidney stones are
- pains in muscles and pains in joints. Some patients have had such severe cramps or back pain that they have had to be treated in a hospital.
- increase in the amount of calcium in the blood
- increase in the amount of uric acid in the blood
- increase in an enzyme called alkaline phosphatase
Rare (may affect up to 1 in 1,000 people):
- impaired renal function, including renal failure
- swelling, mainly in the hands, feet, and legs.
How to store Terrosa
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and the cartridge one after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C–8 °C). Do not freeze.
Store cartridge one in the outer carton. Light sensitive.
Terrosa can be used up to 28 days after the first injection, as long as the cartridge/pen with the cartridge inserted is stored in a refrigerator (2°C to 8°C).
Avoid placing the cartridges near the freezer section of the refrigerator to prevent them from freezing. Do not use Terrosa if it is or has been frozen.
Each cartridge should be discarded after 28 days from the first use, even if it is not empty.
Terrosa contains a clear and colorless solution. Do not use Terrosa if solid particles are visible in the solution or if the solution is cloudy or colored.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is teriparatide. Each 80-microliter dose contains 20 micrograms of teriparatide. A 2.4 ml cartridge contains 600 micrograms of teriparatide (equivalent to 250 micrograms per ml).
- Other ingredients are: concentrated acetic acid, mannitol, metacresol, sodium acetate trihydrate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections (see section 2 “Terrosa contains sodium”.
Appearance and package sizes of the medicine
Terrosa is a colorless and clear solution for injection ( injection ). It is supplied in a cartridge. Each cartridge contains 2.4 ml of solution, which is enough for 28 doses.
Pack sizes: 1 cartridge or 3 cartridges packed on a plastic tray sealed with a foil lid and packed in a carton.
Terrosa ampoule and pen packaging: 1 Terrosa cartridge packed on a plastic tray sealed with a foil lid and packed in an inner pack, and 1 Terrosa Pen packed in an inner pack.
Not all pack sizes may be marketed.
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