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Protaxos

INN: Strontium Ranelate

 

TRADE NAME OF THE MEDICINAL PRODUCT

PROTAXOS 2g granules for oral suspension

 

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains 2g of strontium ranelate.

 

PHARMACEUTICAL FORM

Granules for oral suspension

Yellow granules

 

THERAPEUTIC INDICATIONS

Treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.

 

POSOLOGY AND METHOD OF ADMINISTRATION

The recommended daily dose is one 2g sachet once daily by oral administration. Due to the nature of the treated disease, strontium ranelate is intended for long-term use.

 

The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, PROTAXOS should be administered in-between meals. Given the slow absorption, PROTAXOS should be taken at bedtime, preferably at least two hours after eating.

 

The granules in the sachets must be taken as a suspension in a glass of water. Although in-use studies have demonstrated that strontium ranelate is stable in suspension for 24 hours after preparation, the suspension should be drunk immediately after being prepared.

 

Patients treated with strontium ranelate should receive vitamin D and calcium supplements if dietary intake is inadequate.

 

Use in the elderly

The efficacy and safety of strontium ranelate have been established in a broad age range (up to 100 years at inclusion) of postmenopausal women with osteoporosis. No dosage adjustment is required in relation to age.

 

Use in renal impairment

No dosage adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance). Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30 ml/min).

 

Use in hepatic impairment

As strontium ranelate is not metabolised, no dosage adjustment is required in patients with hepatic impairment.

 

Use in children and adolescents

The efficacy and safety of strontium ranelate have not been established in children and adolescents and use in these age groups is not recommended.

 

CONTRA-INDICATIONS

Hypersensitivity to the active substance or to any of the excipients.

 

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

In the absence of bone safety data in patients with severe renal impairment treated with strontium ranelate, PROTAXOS is not recommended in patients with a creatinine clearance below 30 ml/min. In accordance with good medical practice, periodic assessment of renal function is recommended in patients with chronic renal impairment. Continuation of treatment with PROTAXOS in patients developing severe renal impairment should be considered on an individual basis.

 

In phase III placebo-controlled studies, strontium ranelate treatment was associated with an increase in the annual incidence of venous thromboembolism (VTE), including pulmonary embolism. The cause of this finding is unknown. PROTAXOS should be used with caution in patients at increased risk of VTE, including patients with a past history of VTE. When treating patients at risk, or developing risk of VTE, particular attention should be given to possible signs and symptoms of VTE and adequate preventive measures taken.

 

Strontium interferes with colorimetric methods for the determination of blood and urinary calcium concentrations. Therefore, in medical practice, inductively coupled plasma atomic emission spectrometry or atomic absorption spectrometry methods should be used to ensure an accurate assessment of blood and urinary calcium concentrations.

 

PROTAXOS contains a source of phenylalanine, which may be harmful for people with phenylketonuria.

 

Treatment with PROTAXOS should be discontinued in case of serious allergic reaction.

 

Cases of severe hypersensitivity syndromes, including, in particular, drug rash with eosinophilia and systemic symptoms (DRESS), sometimes fatal, have been reported with the use of PROTAXOS. The DRESS syndrome is characterised by rash, fever, eosinophilia and systemic involvement (e.g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease). Time to onset was usually around 3-6 weeks and the outcome in most severe cases favourable upon discontinuation of PROTAXOS and after initiation of corticosteroid therapy. Recovery could be slow and recurrences of the syndrome have been reported in some cases after discontinuation of corticosteroid therapy.

 

Patients should be informed to stop PROTAXOS immediately and permanently when a rash occurs and to seek medical advice. Patients who have stopped treatment due to hypersensitivity reactions should not re-start therapy with PROTAXOS.

 

INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION

Food, milk and derivative products, and medicinal products containing calcium may reduce the bioavailability of strontium ranelate by approximately 60-70%. Therefore, administration of PROTAXOS and such products should be separated by at least two hours.

 

An in vivo clinical interaction study showed that the administration of aluminium and magnesium hydroxides either two hours before or together with strontium ranelate caused a slight decrease in the absorption of strontium ranelate (20-25% AUC decrease), while absorption was almost unaffected when the antacid was given two hours after strontium ranelate. It is therefore preferable to take antacids at least two hours after PROTAXOS. However, when this dosing regimen is impractical due to the recommended administration of PROTAXOS at bedtime, concomitant intake remains acceptable.

 

As divalent cations can form complexes with oral tetracycline and quinolone antibiotics at the gastro-intestinal level and thereby reduce their absorption, simultaneous administration of strontium ranelate with these medicinal products is not recommended. As a precautionary measure, PROTAXOS treatment should be suspended during treatment with oral tetracycline or quinolone antibiotics.

 

No interaction was observed with oral supplementation of vitamin D. No evidence of clinical interactions or relevant increase of blood strontium levels with medicinal products expected to be commonly prescribed concomitantly with PROTAXOS in the target population were found during clinical trials. These included: nonsteroidal anti-inflammatory agents (including acetylsalicylic acid), anilides (such as paracetamol), H2 blockers and proton pump inhibitors, diuretics, digoxin and cardiac glycosides, organic nitrates and other vasodilators for cardiac diseases, calcium channel blockers, beta blockers, ACE inhibitors, angiotensin II antagonists, selective beta-2 adrenoceptor agonists, oral anticoagulants, platelet aggregation inhibitors, statins, fibrates and benzodiazepine derivatives.

 

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