20 micrograms/80 microliters solution for injection in pre-filled pen teriparatide
What Teriparatide Teva is and what it is used for
Teriparatide Teva contains the active substance teriparatide, which is used to make bones stronger and reduce the risk of bone fractures by stimulating bone formation.
Teriparatide Teva 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 corticosteroids.
The teriparatide contained in Teriparatide Teva may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What you need to know before you use Teriparatide Teva
Do not use Teriparatide Teva
- if you are allergic to teriparatide or any of the other ingredients of this medicine (listed in section 6).
- if you have an increased amount of calcium in the blood (hypercalcemia).
- if you have severe kidney problems.
- if you have previously been diagnosed with bone cancer or other cancer that 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 (a disease with abnormal changes in the bones of the skeleton). 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
Teriparatide Teva may cause an increased amount of calcium in the blood or urine.
Talk to your doctor or pharmacist before or while using Teriparatide Teva:
- 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. Therefore, inject the first doses of Teriparatide Teva where you can quickly sit or lie down if you feel dizzy.
The recommended treatment period of 24 months should not be exceeded.
Teriparatide Teva should not be used in young adults.
Children and young people
Teriparatide Teva should not be used in children or adolescents (under 18 years of age).
Other medicines and Teriparatide Teva
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines. This is because in some cases they can affect the effect of each other (eg digoxin/digitalis, a medicine for the treatment of heart disease).
Pregnancy, breastfeeding, and fertility
Do not use Teriparatide Teva if you are pregnant or breastfeeding. If you are a fertile woman, you should use a safe method of contraception during treatment with Teriparatide Teva. If you become pregnant, treatment with Teriparatide Teva should be stopped. Consult your doctor or pharmacist before taking any medicine.
Driving ability and use of machinery
Some people may feel dizzy after injection with Teriparatide Teva. If you feel dizzy, do not drive or use tools or machines until you feel better.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Teriparatide Teva 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 Teriparatide Teva
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 20 micrograms, which is injected under the skin ( subcutaneously ) 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.
Inject Teriparatide Teva every day for as long as prescribed by the doctor. The total duration of treatment with Teriparatide Teva should not exceed 24 months. You should not receive more than one 24-month course of treatment in your lifetime.
Teriparatide Teva can be taken with a meal.
Read the instructions for use, which can be found in the packaging and further down in this text, under the heading User instructions, how to use the Teriparatide Teva pen.
Needles are not included in the package. Becton Dickinson injection needles for pens 29 to 31 gauge (diameter 0.25-0.33 mm) and length 12.7, 8, or 5 mm can be used.
Inject Teriparatide Teva immediately after removing the pen from the refrigerator, as described in the instructions for use. Return the pan to the refrigerator immediately after use. Use a new needle for each injection and discard it after use. Do not store the pen with the needle attached. Never share your Teriparatide Teva pen with others.
In addition to Teriparatide Teva, your doctor may prescribe supplements of calcium and vitamin D. How much of these medicines you should take each day is determined by your doctor.
Teriparatide Teva can be taken without regard to meals.
If you have used too much Teriparatide Teva
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Too large a dose can cause nausea, vomiting, dizziness, and headache.
If you forget to use Teriparatide Teva or cannot take it at the usual time,
take an injection as soon as possible on the same day. Do not take a double dose to make up for a missed dose. Do not take more than one injection on the same day. Do not try to make up for the missed dose.
If you stop using Teriparatide Teva
If you are considering stopping Teriparatide Teva treatment, you should talk to your doctor. Your doctor will consult with you and decide how long you should continue with Teriparatide Teva.
If you have further questions about this medicine, contact 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 pain in the arms and legs (frequency: very common, may affect more than 1 in 10 users) and nausea, headache, and dizziness (frequency: common). If you feel dizzy after injection one, sit or lie down until you feel better. If you do not improve, a doctor should be contacted before continuing the treatment. Cases of fainting have been reported with the use of teriparatide.
If you feel discomfort such as skin redness, pain, swelling, itching, bruising or minor bleeding at the injection site (frequency: common), this usually disappears within a few days or weeks.
Otherwise, a doctor should be contacted as soon as possible.
Some patients have experienced allergic reactions shortly after injection, such as shortness of breath, facial swelling, rash, and chest pain (frequency: rare). In rare cases, serious and potentially life-threatening allergic reactions including anaphylactic reactions may occur.
If you experience any of these symptoms, stop using Teriparatide Teva and contact your doctor immediately.
Other side effects are:
Common (may affect up to 1 in 10 users):
- increased cholesterol levels in the blood
- Depression
- neuralgic (nerve) pain in the legs
- feeling of weakness
- 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)
- nausea (vomiting)
- hernia in the esophagus
- low hemoglobin or low red blood cell count ( anemia ).
Uncommon (may affect up to 1 in 100 users):
- 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 had to be treated in the 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 users)
- impaired renal function, including renal failure
- swelling, mainly in the hands, feet, and legs.
How to store Teriparatide Teva
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and pen after EXP. The expiration date is the last day of the specified month.
Teriparatide Teva should always be stored in a refrigerator (2 o C – 8 o C) both in unopened and opened packaging. Teriparatide Teva can be used for up to 28 days after the first injection, as long as the pen is stored in a refrigerator (2 o C – 8 o C).
Teriparatide Teva must not be frozen. Avoid placing the pens near the freezer section of the refrigerator to prevent them from freezing. Do not use Teriparatide Teva if it is or has been frozen.
After 28 days, the pen must be discarded, even if it is not empty.
Teriparatide Teva contains a clear and colorless solution. Do not use this medicine if solid particles have formed 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. A pre-filled pen of 2.4 ml contains 600 micrograms of teriparatide (equivalent to 250 micrograms per ml)
- Other ingredients are concentrated acetic acid, sodium acetate trihydrate, mannitol, metacresol, and water for injections. In addition, hydrochloric acid solution and/or sodium hydroxide solution may have been added for pH adjustment.
Appearance and package sizes of the medicine
Teriparatide Teva is a colorless and clear solution. It is supplied in an ampoule enclosed in a pre-filled pen. Each pen contains 2.4 ml of solution, which is enough for 28 doses. The package contains either 1 or 3 pens or a multipack with 3 pens (3 packages with 1 pen).
Not all pack sizes may be provided.