Teriparatide (recombinant DNA origin)
Glacial Acetic Acid
Sodium Hydroxide c.s.p
Water for injection c.s.p.
pH = 4,0
Osteofortil® is the first choice treatment to prevent fractures, whether vertebral as well as nonvertebral in menopausal women with severe osteoporosis.
• Postmenopausal women with prior osteoporotic fracture.
• Patients on chronic corticoid therapy (5 mg of prednisone or equivalent for more than 3 months).
• Postmenopausal men and women with severe osteoporosis (defined as more than one fracture by fragility and very low bone mineral density, (T-score < -3.5).
• Women older than 65 years old with T-score <-2.5 and prevailing vertebral fracture.
Teriparatide is administered by IV injection, which quickly passes to the bloodstream, where it is excreted through hepatic and extrahepatic clearance (about 62 L/hour in women and 94 L/hour in men). The distribution volume is about 1.7 L/kg. Teriparatide's half-life is about 1 hour when administered subcutaneously. No studies of metabolism or excretion with teriparatide have been performed, but it is believed that the peripheral metabolism of the parathyroid hormone is mainly produced in the kidney and liver.
If used in the vial, the cap must be cleaned with a cloth or gauze embedded in alcohol before administration; afterward, 80 microliters of the injection solution must be taken (with a syringe prescribed by the doctor). This volume contains 20 micrograms (recommended daily dose). If a prefilled syringe is used, the patient must use a syringe per day and discard it after use.
A calcium and vitamin D supplement is recommended in patients with a low intake of these nutrients in the diet. In order to remember the administration, we recommend injecting OSTEOFORTIL® at the same time every day.
• OSTEOFORTIL® recommended dose is 20 micrograms.
• Administration: once a day by subcutaneous injection in thigh or abdomen.
• Total duration of treatment must not exceed 24 months. The patient must not be administered more than one 24-month cycle of treatment with teriparatide in his life.
• OSTEOFORTIL® may be injected at meal time or in any other time.
• In case you forget administration or you cannot inject OSTEOFORTIL® at the regular time, we recommend doing it as soon as possible that day.
• Do not apply a double dose to compensate forgotten doses.
• Hypersensitivity to the drug substance or any excipients.
• Pregnancy and breastfeeding.
• Pre-existing hypercalcemia.
• Acute kidney failure.
• Patients with metabolic bone disease different from primary osteoporosis (including
hyperparathyroidism and Paget’s disease of bone).
• Unexplained increases of alkaline phosphatase.
• Patients who have previously been administered external radiation or radiotherapy localized on
• Patients with bone tumor or bone metastasis must be excluded from teriparatide treatment.
Precautions and warnings
• Do not administer if you have ever been diagnosed bone cancer or any other types of cancer
affecting your bones.
• Do not administer in cases of Paget’s disease of bone or high levels of alkaline phosphatase in
blood with no apparent reason.
• Do not administer to patients who have received radiotherapy with potential damage to their bones.
• If the patient feels dizzy after an injection, he/she must sit down or lie down until he/she feels better.
• If he/she does not feel better, he/she must see a doctor before continuing with treatment.
• OSTEOFORTIL® may increase calcium in blood. If there is too much calcium in blood, nausea,
vomits, constipation, low energy or muscle weakness may occur.
• OSTEOFORTIL® may increase calcium in urine. In case of previous renal lithiasis or the onset of
renal lithiasis during treatment, treatment should be evaluated.
• Treatment should be reevaluated in case of kidney failure.
• In the first doses, administer OSTEOFORTIL® in a place where the patient may sit down or lie
down immediately if he feels dizzy, as this drug may cause dizziness or increased heart rate.
Osteofortil: adverse events
Frequent adverse events (10 out of 100 patients)
• General discomfort
• Pain in arms or legs
Frequent adverse events (1-10 out of 100 patients)
• Neuralgic pain in leg
• Chest pain
• Fainting sensation
• Difficulty to breathe
• Muscular cramps
• Increased sweat
• Higher levels of cholesterol in blood
• Loss of energy
Uncommon Adverse Events (1-10 out 1,000 patients)
• Increased heart rate
• Low blood pressure
• Shortness of breath
• Muscular pain
• Joint pain
• Gastric acidity (pain or burning sensation
just belows the sternum)
• Increased need to urinate
• Discomfort such as redness, skin pain
Rare Adverse Events (1-10 out of 10,000 patients)
• Swelling, mainly in hands, feet and legs
• Cramps or severe backache
• Immediately after the injection: difficulty to breathe, face swelling, skin rash and chest pain.
Antagonisms and antidotes
No antidotes are available. In case of intoxication, the patient must be taken to the nearest health center.
No pharmacological interactions.
Osteofortil® must not be administered after the expiration date included in the package and/or the vial or syringe.
Osteofortil® must always be stored in the fridge (between 2 ºC and 8 ºC).
Do not freeze OSTEOFORTIL®. Do not place vials or syringes with product near the freezer inside the fridge in order to prevent freezing.
Each vial must be duly discarded after 28 days of use, although it is not empty.