Eladynos

Posology The recommended dose is 80 micrograms once daily. 1). Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Following cessation of abaloparatide therapy, patients may be continued on other osteoporosis therapies such as bisphosphonates.

Missed dose If a patient forgets or cannot administer their dose at the usual time, it can be injected within 12 hours of the normally scheduled time. Patients should not administer more than one injection in the same day and should not try to make up for a missed dose.

2). 3). 2). Hepatic impairment No data are available in patients with impaired hepatic function. 2). 3). Method of administration For subcutaneous use only. 4). 6). A detailed instruction for use is included in each pack to instruct patients on the correct use of the injection pen.

Abaloparatide should be injected in the lower abdomen. The site of the injection should be rotated every day. Injections should be administered at approximately the same time every day.

6%). 4% of the placebo patients reported at least 1 adverse event. The adverse reactions associated with the use of abaloparatide in osteoporosis in the ACTIVE study and in postmarketing exposure are summarised in the table below. The following MedDRA convention has been used for the classification of the adverse reactions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), and frequency not known (cannot be estimated from the available data).

5 beats per minute (bpm) 15 minutes after administration. This increase in heart rate was most prominent during the first hour post dose but was seen up to 6 hours in some subjects. In the ACTIVE study, heart rate was measured one hour post dose of every study visit, with median heart rate increase from pre-dose of 14 bpm in abaloparatide treated patients as compared to 7 bpm in placebo treated patients.

Patients with >20 bpm increase in heart rate at 1 hour after the first dose were more likely to experience palpitations and/or increases in heart rate >20 bpm during subsequent treatment. 4% of patients in the placebo group. 6% of patients in the placebo group.

7 Injection site reactions Abaloparatide can cause injection site reactions including injection site bruising, erythema, haemorrhage, hypersensitivity, pain, rash, and swelling. 0% in the placebo group. Laboratory findings Serum calcium Abaloparatide can cause transient increases in serum calcium levels measured 4 hours post-dose.

4%). Serum uric acid Abaloparatide increased serum uric acid concentrations. In the ACTIVE study, 25% of patients in the abaloparatide group had normal baseline uric acid concentrations which were increased above the normal range at post-baseline, compared with 5% in the placebo group.

00113 mmol/μmol (or >400 mg/g) was higher with abaloparatide than with placebo (20% vs 15%, respectively). 2% of placebo-treated patients. 5% developed in vitro neutralising antibodies. Formation of anti-abaloparatide antibodies is associated with increased clearance of abaloparatide.

Orthostatic hypotension and increased heart rate Orthostatic hypotension and transient episodes of increase in heart rate may occur with abaloparatide, typically within 4 hours of injection. Symptoms may include dizziness, palpitations, tachycardia, or nausea, and may resolve by having the patient lie down.

The first injection(s) of abaloparatide should be performed under the guidance of an appropriately qualified health care professional who may observe the 4 patient during the first hour after injection. Abaloparatide should always be administered where the patient can sit or lie down if necessary.

Abaloparatide may have vasodilating effect on vascular smooth muscle and positive chronotropic/inotropic effects on cardiac muscle. Individual benefit risk assessment is important. Blood pressure, cardiac status and ECG should be assessed prior to beginning treatment with abaloparatide.

Patients with cardiac disease should be monitored for worsening of their disease. If severe orthostatic hypotension or severe cardiovascular symptoms occur, the treatment should be discontinued. Hypercalcaemia In normocalcaemic patients, transient elevations of serum calcium concentrations have been observed following abaloparatide injection.

Serum calcium concentrations reach a maximum at approximately 4 hours and return to baseline by 24 hours after each dose. Therefore, if blood samples for serum calcium measurements are taken, this should be done approximately 24 hours after the most recent injection.

Routine calcium monitoring during therapy is not required in patients without additional risk factors for hypercalcaemia. Hypercalciuria and urolithiasis Abaloparatide may cause hypercalciuria. It is unknown whether abaloparatide may exacerbate urolithiasis in patients with active or a history of urolithiasis.

If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered. Duration of treatment The maximum total duration of treatment with abaloparatide should be 18 months.

3) - Patients with skeletal malignancies or bone metastases