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Forsteo, INN-Teriparatide

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Forsteo, INN-Teriparatide ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT FORSTEO 20micrograms/80 microliters, solution for injection, in pre-filled pen . 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled pen of 3 ml contains 750 micrograms of teriparatide (corresponding to 250 micrograms per ml). Each dose contains 20 micrograms of teriparatide. The pre-filled pen is intended for 28 days of dosing. Teriparatide, rhPTH(1-34), (FORSTEO), produced in E. coli, using recombinant DNA technology, is identical to the 34 N-terminal amino acid sequence of endogenous human parathyroid hormone. For excipients, see 6.1 3. PHARMACEUTICAL FORM Solution for injection in a pre-filled pen. Colourless, clear solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of established osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. 4.2 Posology and method of administration The recommended dose of FORSTEO is 20 micrograms administered once daily by subcutaneous injection in the thigh or abdomen. Patients must be trained to use the proper injection techniques (see section 6.6). A User Manual is also available to instruct patients on the correct use of the pen. The maximum total duration of treatment with FORSTEO should be 18 months (see section 4.4 Special warnings and special precautions for use). Patients should receive supplemental Calcium and vitamin D supplements if dietary intake is inadequate. Following cessation of FORSTEO therapy, patients may be continued on other osteoporosis therapies. Use in renal impairment: FORSTEO should not be used in patients with severe renal impairment (see 4.3. Contraindications). In patients with moderate renal impairment, FORSTEO should be used with caution. Use in hepatic impairment: no data are available in patients with impaired hepatic function (see section 5.3. Preclinical safety data). Specific populations: Children: FORSTEO has not been studied in paediatric populations. FORSTEO should not be used in paediatric patients or young adults with open epiphyses. 2 Elderly patients: Dosage adjustment based on age is not required (See 5.2. Pharmacokinetic properties). 4.3 Contraindications • Hypersensitivity to teriparatide or any of its excipients. • Pre-existing hypercalcemia • Severe renal impairment • Metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism and Paget’s disease of the bone) • Unexplained elevations of alkaline phosphatase • Prior external beam or implant radiation therapy to the skeleton • Patients with skeletal malignancies or bone metastases should be excluded from treatment with teriparatide. 4.4 Special warnings and special precautions for use In normocalcemic patients, slight and transient elevations of serum calcium concentrations have been observed following teriparatide injection. Serum calcium concentrations reach a maximum between 4 and 6 hours and return to baseline by 16 to 24 hours after each dose of teriparatide. Routine calcium monitoring during therapy is not required. Therefore if any blood samples are taken from a patient, this should be done at least 16 hours after the most recent FORSTEO injection. FORSTEO may cause small increases in urinary calcium excretion, but the incidence of hypercalciuria did not differ from that in the placebo-treated patients in clinical trials. FORSTEO has not been studied in patients with active urolithiasis. FORSTEO should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition. In short-term clinical studies with FORSTEO, isolated episodes of transient orthostatic hypotension were observed. Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours. When transient orthostatic hypotension occurred, it happened within the first several doses, was relieved by placing subjects in a reclining position, and did not preclude continued treatment. Caution should be exercised in patients with moderate renal impairment. Studies in rats indicate an increased incidence of osteosarcoma with long-term administration of teriparatide (see section 5.3). Until further clinical data become available, the recommended treatment time of 18 month should not be exceeded. 4.5 Interactions with other medicinal products and other forms of interaction FORSTEO has been evaluated in pharmacodynamic interaction studies with hydrochlorothiazide. No clinically significant interactions were noted. Co-administration of raloxifene or hormone replacement therapy with FORSTEO did not alter the effects of FORSTEO on serum or urine calcium or on clinical adverse events. In a study of 15 healthy subjects administered digoxin daily to steady state, a single FORSTEO dose did not alter the cardiac effect of digoxin. However, sporadic case reports have suggested that 3 hypercalcemia may predispose patients to digitalis toxicity. Because FORSTEO transiently increases serum calcium, FORSTEO should be used with caution in patients taking digitalis. 4.6 Pregnancy and lactation Studies in rabbits have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Given the indication, FORSTEO should not be used during pregnancy or by breast-feeding women. 4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed. However, transient, orthostatic hypotension or dizziness was observed in some patients. These patients should refrain from driving or the use of machines until symptoms have subsided. 4.8 Undesirable effects Of patients in the teriparatide trials, 82.8% of the FORSTEO patients and 84.5% of the placebo patients reported at least 1 adverse event. The most commonly reported adverse events in patients treated with FORSTEO are nausea, pain in limb, headache and dizziness. Tables 1, 2 and 3 give an overview of all treatment emergent adverse events that were observed in the trial populations, irrespective of causal relationship. The following events were observed in clinical trials in 1382 patients. Table 1 Very Common Adverse Events ( ≥ 10%) FORSTEO Placebo System Organ Class Adverse Event N=691 N=691 (%) (%) Musculoskeletal and Connective Tissue Pain in limb 10.0 9.0 and Bone Disorders Table 2 Common Adverse Events ( ≥ 1%, < 10%) FORSTEO Placebo System Organ Class Adverse Event N=691 N=691 (%) (%) Blood and Lymphatic System Disorders Anaemia 1.7 1.3 Metabolism and Nutrition Disorders Hypercholesterolaemia 2.6 2.3 Psychiatric Disorders Depression 4.1 2.5 Nervous System Disorders Headache 7.7 7.4 Dizziness 8.0 5.2 Sciatica 1.3 0.7 Ear and Labyrinth Disorders Vertigo 3.6 2.5 Cardiac Disorders Palpitations 1.4 1.2 Vascular Disorders Hypotension 1.0 1.0 Respiratory, Thoracic and Mediastinal Dyspnoea 3.3 2.3 Disorders Gastrointestinal Disorders Nausea 8.5 6.2 Vomiting 3.3 2.6 Hiatus Hernia 1.0 0.9 Gastroesophageal reflux disease 1.0 0.4 Skin and Subcutaneous Tissue Sweating increased 1.9 1.3 Disorders Musculoskeletal and Connective Tissue Muscle cramps 3.6 2.9 and Bone Disorders General Disorders and Administration Fatigue 4.8 4.3 4 Site Conditions Chest pain 3.8 3.5 Asthenia 1.6 1.2 Table 3 Uncommon Adverse Events ( ≥ 0.1%, <1%) FORSTEO Placebo System Organ Class Adverse Event N=691 N=691 (%) (%) Cardiac Disorders Tachycardia 0.9 0.9 Respiratory, Thoracic and Mediastinal Emphysema 0.3 0 Disorders Gastrointestinal Disorders Haemorrhoids 0.9 0.4 Renal and Urinary Disorders Urinary incontinence 0.6 0.3 Polyuria 0.3 0.1 Micturition urgency 0.3 0 General Disorders and Administration Injection site erythema 0.7 0 Site Conditions Injection site reaction 0.3 0.1 Investigations Weight increased 0.7 0.3 Cardiac murmur 0.4 0.1 FORSTEO increases serum uric acid concentrations. In clinical trials, 2.8% of FORSTEO patients had serum uric acid concentrations above the upper limit of normal compared with 0.7% of placebo patients. However, the hyperuricemia did not result in an increase in gout, arthralgia, or urolithiasis. In a large clinical trial, antibodies that cross-reacted with teriparatide were detected in 2.8% of women receiving FORSTEO. Generally, antibodies were first detected following 12 months of treatment and diminished after withdrawal of therapy. There was no evidence of hypersensitivity reactions, allergic reactions, effects on serum calcium, or effects on BMD response. The following table of adverse reactions is based on post-marketing spontaneous reports. The following convention has been used for the classification of the adverse reactions: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000) very rare (<1/10,000). System Organ Class Adverse reactions General Disorders and Administration Rare: Possible allergic events soon after injection: acute Site Conditions dyspnoea, oro/facial oedema, generalized urticaria, chest pain. Common: Mild and transient injection site events, including pain, swelling, erythema, localised bruising, pruritis and minor bleeding at injection site. Metabolism and Nutrition Disorders Uncommon: Hypercalcemia greater than 2.76 mmol/l (11mg/dl). Rare: Hypercalcemia greater than 3.25 mmol/l (13mg/dl). Musculoskeletal and Connective Tissue Uncommon: myalgia, arthralgia, and Bone Disorders 4.9 Overdose Signs and symptoms No cases of overdose were reported during clinical trials. FORSTEO has been administered in single doses of up to 100 micrograms and
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