Changes

 Added (underline) deleted (strikethrough)

 Formatting changes throughout in line with current readability expectations.

4.4       Special warnings and precautions for use

[…]

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number

of the administered product should be clearly recorded.

[…]

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

[…]

4.8       Undesirable effects

[…]

Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517; website: www.hpra.ie; e-mail: medsafety@hpra.ie,

[…]

10.       DATE OF REVISION OF THE TEXT 

            09 November 201714 October 2020

Changes

 Added (underline) deleted (strikethrough)

 Formatting changes throughout in line with current readability expectations.

Title

FORSTEO^® 20 micrograms/80 microliters solution for injection in pre-filled pen

Tteriparatide

4.         Possible side effects

[…]

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, website: www.hpra.ie, e-mail: medsafety@hpra.ie,

[…]

6.             Contents of the pack and other information

[…]

This leaflet was last revised in June 2018 October 2020

[…]

Changes

Added (underline) deleted (strikethrough)

Changed FORSTEO to Forsteo throughout in line with current readability expectations.

4.8       Undesirable effects

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517; website: www.hpra.ie; e-mail: medsafety@hpra.ie, or United Kingdom: Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. UK: www.mhra.gov.uk/yellowcard or Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, www.hpra.ie, medsafety@hpra.ie.

5.1       Pharmacodynamic properties

A 24-month, randomized, double-blind, comparator-controlled Phase 4 study included 1,360 postmenopausal women with established osteoporosis. 680 subjects were randomised to Forsteo and 680 subjects were randomised to oral risedronate 35 mg/week. At baseline, the women had a mean age of 72.1 years and a median of 2 prevalent vertebral fractures; 57.9% of patients had received previous bisphosphonate therapy and 18.8% took concomitant glucocorticoids during the study. 1,013 (74.5%) patients completed the 24-month follow-up. The mean (median) cumulative dose of glucocorticoid was 474.3 (66.2) mg in the teriparatide arm and 898.0 (100.0) mg in the risedronate arm. The mean (median) vitamin D intake for the teriparatide arm was 1433 IU/day (1400 IU/day) and for the risedronate arm was 1191 IU/day (900 IU/day). For those subjects who had baseline and follow-up spine radiographs, the incidence of new vertebral fractures was 28/516 (5.4%) in Forsteo- and 64/533 (12.0%) in risedronate-treated patients, relative risk (95% CI) = 0.44 (0.29-0.68), P<0.0001. The cumulative incidence of pooled clinical fractures (clinical vertebral and non vertebral fractures) was 4.8% in Forsteo and 9.8% in risedronate-treated patients, hazard ratio (95% CI) = 0.48 (0.32-0.74), P=0.0009.

10.       DATE OF REVISION OF THE TEXT

            01 January 201609 November 2017

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.

*FORSTEO (teriparatide) is a trademark of Eli Lilly and Company.        FS17MFS18M

Upload to change category from 'HCP' to 'Patient'.

Changes

Added (underline) deleted (strikethrough)

Changed FORSTEO to Forsteo throughout in line with current readability expectations.

4.8       Undesirable effects

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517; website: www.hpra.ie; e-mail: medsafety@hpra.ie, or United Kingdom: Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. UK: www.mhra.gov.uk/yellowcard or Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, www.hpra.ie, medsafety@hpra.ie.

5.1       Pharmacodynamic properties

A 24-month, randomized, double-blind, comparator-controlled Phase 4 study included 1,360 postmenopausal women with established osteoporosis. 680 subjects were randomised to Forsteo and 680 subjects were randomised to oral risedronate 35 mg/week. At baseline, the women had a mean age of 72.1 years and a median of 2 prevalent vertebral fractures; 57.9% of patients had received previous bisphosphonate therapy and 18.8% took concomitant glucocorticoids during the study. 1,013 (74.5%) patients completed the 24-month follow-up. The mean (median) cumulative dose of glucocorticoid was 474.3 (66.2) mg in the teriparatide arm and 898.0 (100.0) mg in the risedronate arm. The mean (median) vitamin D intake for the teriparatide arm was 1433 IU/day (1400 IU/day) and for the risedronate arm was 1191 IU/day (900 IU/day). For those subjects who had baseline and follow-up spine radiographs, the incidence of new vertebral fractures was 28/516 (5.4%) in Forsteo- and 64/533 (12.0%) in risedronate-treated patients, relative risk (95% CI) = 0.44 (0.29-0.68), P<0.0001. The cumulative incidence of pooled clinical fractures (clinical vertebral and non vertebral fractures) was 4.8% in Forsteo and 9.8% in risedronate-treated patients, hazard ratio (95% CI) = 0.48 (0.32-0.74), P=0.0009.

10.       DATE OF REVISION OF THE TEXT

            01 January 201609 November 2017

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.

*FORSTEO (teriparatide) is a trademark of Eli Lilly and Company.        FS17MFS18M

Changes

Added (bold), Deleted (strikethrough):

7.      MARKETING AUTHORISATION HOLDER
 Eli Lilly Nederland B.V., Grootslag 1‑5 NL‑3991 RA, HoutenPapendorpseweg 83, 3528 BJ Utrecht, The Netherlands

10.     DATE OF REVISION OF THE TEXT

25 April 201401 January 2016

New text underlined, deleted text struck through

4.8          Undesirable effects

Summary of the safety profile

The most commonly reported adverse reactions in patients treated with FORSTEO are nausea, pain in limb, headache and dizziness.

Tabulated list of adverse reactions

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 adverse reactions associated with the use of teriparatide in osteoporosis clinical trials and post-marketing exposure are summarised in the table below. The following 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)

…..

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via UK: www.mhra.gov.uk/yellowcard or Ireland: IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, www.imb.ie, imbpharmacovigilance@imb.ie.

9.             DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation:  10 June 2003

Date of the last renewal: 10 June 2008 2013

10.       DATE OF REVISION OF THE TEXT

13 February 2013 25 April 2014

No new safety information has been added, only format and template changes in all sections.

In Section 10, date of revision is updated.

Internal change, reference to Forsteo 3ml pen removed. It was replaced by the 2.4ml pen, 2 years ago, and the 3 ml pen has been gradually phased out.

In Section 2, Qualitative and quantitative composition, the following text is deleted – ‘One pre-filled pen of 2.4 ml contains 600 micrograms of teriparatide (corresponding to 250 micrograms per ml). Or’

In Section 6.5, Nature and contents of container, the following text is deleted – ‘3ml solution in cartridge (siliconised Type I glass) with a plunger (halobutyl rubber), disc seal (polyisoprene/bromobutyl rubber laminate) and crimp cap (aluminium) assembled into a disposable pen. Or’

In Section 4.8 Undesirable effects, Nervous system disorders – Syncope moved from ‘Not known’ to ‘Common’; Renal and Urinary disorders – Nephrolithiasis added to ‘Uncommon’; Renal failure/impairment moved from ‘Not known’ to ‘Rare’; Musculoskeletal and connective tissue disorders - Back cramp/pain moved from ‘Not known’ to ‘Uncommon’

In Section 10 Date of revision of the text, the date of revision is updated.

4.6       Pregnancy and lactation

            Change to section 4.6 sub-section heading (QRD template change)

- to  4.6  Fertility, Ppregnancy and lactation.

5.1       Pharmacodynamic properties

Correction of table number & cross reference to table (table number) – from Table 4 to Table 1.

10.       DATE OF REVISION OF THE TEXT

New date (as previous date)

27 May 2011

This SPC has been revised to remove the black triangle symbol (affecting UK SPC version only) – there are no other content changes.   Accordingly, the Lilly internal SPC code has been updated to FS11M only.

Changes

Added text: ‘in bold, over size’

4.             CLINICAL PARTICULARS

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 reactions in patients treated with FORSTEO are nausea, pain in limb, headache and dizziness.

The undesirable reactions associated with the use of teriparatide in osteoporosis clinical trials and post-marketing exposure are summarised in the table below. The following 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), not known (cannot be estimated from the available data).

* Serious cases of back cramp or pain have been reported within minutes of the injection.

In clinical trials the following reactions were reported at a ≥ 1% difference in frequency from placebo: vertigo, nausea, pain in limb, dizziness, depression, dyspnoea.

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 hyperuricaemia 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.

10.          DATE OF REVISION OF THE TEXT

New date

18 March 2010

4.             CLINICAL PARTICULARS

4.3          Contraindications

Added (bold) deleted (strikethrough):

·                Metabolic bone diseases (including hyperparathyroidism and Paget’s disease of the bone) other than primary osteoporosis or glucorticoid-induced osteoporosis (including hyperparathyroidism and Paget’s disease of the bone).

4.8          Undesirable effects

Added (bold):

The undesirable reactions associated with the use of teriparatide in osteoporosis clinical trials and post-marketing exposure are summarised in the table below.

Renal and urinary disorders

Added:

Not known: Renal failure/impairment

5.            PHARMACOLOGICAL PROPERTIES

5.1          Pharmacodynamic properties

Added (bold) deleted (strikethrough):

Pharmaco-therapeutic group: parathyroid hormones and analogues, ATC code: H05 AA023.

10.          DATE OF REVISION OF THE TEXT

New date

28 August 2009

4.              CLINICAL PARTICULARS

4.2           Posology and method of administration

Deleted (strikethrough) Added (bold):

The maximum total duration of treatment with FORSTEO should be 18 24 months (see section 4.4). The 18 24-month course of FORSTEO should not be repeated over a patients lifetime.

4.4       Special warnings and precautions for use

Deleted (strikethrough) Added (bold):

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  24 months should not be exceeded.

5.         PHARMACOLOGICAL PROPERTIES

5.1           Pharmacodynamic properties

Deleted (strikethrough) Added (bold):

Postmenopausal women Postmenopausal osteoporosis:

Postmenopausal osteoporosis:

Added:

In an open-label study, 503 postmenopausal women with severe osteoporosis and a fragility fracture within the previous 3 years (83%) had received previous osteoporosis therapy) were treated with FORSTEO for up to 24 months. At 24 months, the mean increase from baseline in lumbar spine, total hip and femoral neck BMD was 10.5%, 2.6% and 3.9% respectively. The mean increase in BMD from 18 to 24 months was 1.4%, 1.2%, and 1.6% at the lumbar spine, total hip and femoral neck, respectively.

Glucocorticoid-induced osteoporosis:

Added (bold):

The efficacy of Forsteo in men and women (N=428) receiving sustained systemic glucocorticoid therapy (equivalent to 5 mg or greater of prednisone for at least 3 months) was demonstrated in the 18-month primary phase of a 36-month, randomised, double-blind, comparator-controlled study (alendronate 10 mg/day).

Sixty-nine percent of patients completed the 18-month primary phase.  At the 18-month endpoint, FORSTEO significantly increased lumbar spine BMD (7.2%) compared with alendronate (3.4%) (p<0.001). FORSTEO increased BMD at the total hip (3.6%) compared with alendronate (2.2%) (p<0.01), as well as at the femoral neck (3.7%) compared with alendronate (2.1%) (p<0.05).

Deleted:

A preliminary analysis of 336 spinal X-rays showed that 10 patients in the alendronate group (6.1%) had experienced a new vertebral fracture compared with 1 patient in the FORSTEO group (0.6%). In addition, 9 patients in the alendronate group (4.2%) had experienced a nonvertebral fracture compared with 12 patients in the FORSTEO group (5.6%).

Added:

In patients treated with teriparatide, lumbar spine, total hip and femoral neck BMD increased between 18 and 24 months by an additional 1.7%, 0.9%, and 0.4%, respectively.

At 36 months, analysis of spinal X-rays from 169 alendronate patients and 173 FORSTEO patients showed that 13 patients in the alendronate group (7.7%) had experienced a new vertebral fracture compared with 3 patients in the FORSTEO group (1.7%) (p=0.01). In addition, 15 of 214 patients in the alendronate group (7.0%) had experienced a nonvertebral fracture compared with 16 of 214 patients in the FORSTEO group (7.5%) (p=0.84).

Added (bold):

In premenopausal women, the increase in BMD from baseline to 18 month endpoint was significantly greater in the FORSTEO group compared with the alendronate group at the lumbar spine (4.2% versus −1.9%; p<0.001) and total hip (3.8% versus 0.9%; p=0.005).

5.3       Preclinical safety data

Added (bold):

Rats treated with near-life time daily injections had dose-dependent exaggerated bone formation and increased incidence of osteosarcoma most probably due to an epigenitic mechanism. Teriparatide did not increase the incidence of any other type of neoplasia in rats. Due to the differences in bone physiology in rats and humans, the clinical relevance of these findings is probably minor. No bone tumours were observed in ovariectomised monkeys treated for 18 months nor during a 3-year follow-up period after treatment cessation. In addition, no osteosarcomas have been observed in clinical trials or during the post treatment follow-up study.

10.          DATE OF REVISION OF THE TEXT

New date

25 February 2009

Teriparatide, rhPTH(1-34), (FORSTEO), produced in E. coli, using recombinant DNA technology, is identical to

Paediatric population and young adults with open epiphyses: There is no experience in paediatric patients (less

The most commonly reported adverse reactions in patients treated with FORSTEO are nausea, pain in limb,

common (¡Ý 1/10), common (¡Ý 1/100 to <1/10), uncommon (¡Ý 1/1,000 to <1/100), rare (¡Ý 1/10,000 to <1/1,000)

In clinical trials the following reactions were reported at a ¡Ý 1% difference in frequency from placebo: vertigo,

The following convention has been used for the classification of the adverse reactions: very common (¡Ý 1/10),

common (¡Ý 1/100 to <1/10), uncommon (¡Ý 1/1,000 to <1/100), rare (¡Ý 1/10,000 to <1/1,000) very rare

(up to 800 ¦Ìg)

Pharmaco-therapeutic group: calcium homeostasis, ATC code: H05AA02 parathyroid hormones and

4.             CLINICAL PARTICULARS

4.1          Therapeutic indications

Added:

Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).

4.2          Posology and method of administration

Added (bold text):

The maximum total duration of treatment with FORSTEO should be 18 months (see section 4.4). The 18-month course of FORSTEO should not be repeated over a patient¡¯s lifetime.

4.3                Contraindications

Added (New Bullet):

¡¤                      Pregnancy and lactation (see section 4.4 and 4.6)

4.4          Special warnings and precautions for use

Added:

Experience in the younger adult population, including premenopausal women, is limited (see section 5.1).  Treatment should only be initiated if the benefit clearly outweighs risks in this population.

Women of childbearing potential should use effective methods of contraception during use of FORSTEO. If pregnancy occurs, FORSTEO should be discontinued.

4.6               Pregnancy and lactation

Deleted:

The potential risk for humans is unknown. Given the indication, FORSTEO should not be used during pregnancy or by breast-feeding women.

Added:

General recommendation

Studies in rabbits have shown reproductive toxicity (see section 5.3). The effect of teriparatide on human foetal development has not been studied. The potential risk for humans is unknown.

It is not known whether teriparatide is excreted in human milk.

FORSTEO is contraindicated for use during pregnancy or breast-feeding.

Women of childbearing potential / Contraception in females

Women of childbearing potential should use effective methods of contraception during use of FORSTEO.  If pregnancy occurs, FORSTEO should be discontinued.

Added (bold text):

* Serious cases of back cramp or pain have been reported within minutes of the injection.

5.            PHARMACOLOGICAL PROPERTIES

5.1          Pharmacodynamic properties

Added:

Clinical efficacy

Risk Factors

Premenopausal women with glucocorticoid-induced osteoporosis should be considered at high risk for fracture if they have a prevalent fracture or a combination of risk factors that place them at high risk for fracture (e.g., low bone density [e.g., T score ¡Ü−2], sustained high dose glucocorticoid therapy [e.g., ¡Ý7.5 mg/day for at least 6 months], high underlying disease activity, low sex steroid levels).

Glucocorticoid-induced osteoporosis

The efficacy of Forsteo in men and women (N=428) receiving sustained systemic glucocorticoid therapy (equivalent to 5 mg or greater of prednisone for at least 3 months) was demonstrated in an 18-month, randomised, double-blind, comparator-controlled study (alendronate 10 mg/day). Twenty-eight percent of patients had one or more radiographic vertebral fractures at baseline. All patients were offered 1000 mg calcium per day and 800 IU vitamin D per day.

This study included postmenopausal women (N=277), premenopausal women (N=67), and men (N=83). At baseline, the postmenopausal women had a mean age of 61 years, mean lumbar spine BMD T score of −2.7, median prednisone equivalent dose of 7.5 mg/day, and 34% had one or more radiographic vertebral fractures; premenopausal women had a mean age of 37 years, mean lumbar spine BMD T score of −2.5, median prednisone equivalent dose of 10 mg/day, and 9% had one or more radiographic vertebral fractures; and men had a mean age of 57 years, mean lumbar spine BMD T score of −2.2, median prednisone equivalent dose of 10 mg/day, and 24% had one or more radiographic vertebral fractures.

Sixty-nine percent of patients completed the 18-month study.  At endpoint, FORSTEO significantly increased lumbar spine BMD (7.2%) compared with alendronate (3.4%) (p<0.001). FORSTEO increased BMD at the total hip (3.6%) compared with alendronate (2.2%) (p<0.01), as well as at the femoral neck (3.7%) compared with alendronate (2.1%) (p<0.05).

A preliminary analysis of 336 spinal X-rays showed that 10 patients in the alendronate group (6.1%) had experienced a new vertebral fracture compared with 1 patient in the FORSTEO group (0.6%). In addition, 9 patients in the alendronate group (4.2%) had experienced a nonvertebral fracture compared with 12 patients in the FORSTEO group (5.6%).

In premenopausal women, the increase in BMD from baseline to endpoint was significantly greater in the FORSTEO group compared with the alendronate group at the lumbar spine (4.2% versus −1.9%; p<0.001) and total hip (3.8% versus 0.9%; p=0.005).  However, no significant effect on fracture rates was demonstrated.

5.3          Preclinical safety data

Added (bold text):

Teriparatide was not genotoxic in a standard battery of tests. It produced no teratogenic effects in rats, mice or rabbits. There were no important effects observed in pregnant rats or mice administered teriparatide at daily doses of 30 to 1000 mcg/kg. However, foetal resorption and reduced litter size occurred in pregnant rabbits administered daily doses of 3 to 100 mcg/kg. The embryotoxicity observed in rabbits may be related to their much greater sensitivity to the effects of PTH on blood ionised calcium compared with rodents.

10.          DATE OF REVISION OF THE TEXT

New date

02 April 2008

4.             CLINICAL PARTICULARS

4.8          Undesirable effects

Added ‘oedema (mainly peripheral)’ as a rare adverse reaction in the table listing post-marketing spontaneous reports.

10.          DATE OF REVISION OF THE TEXT

New date

21 August 2007

2.             QUALITATIVE AND QUANTITATIVE COMPOSITION

Added (new text in bold):

For a full list of excipients, see section 6.1.

4.             CLINICAL PARTICULARS

4.1          Therapeutic indications

Deletions in strikethrough text and added text in bold.

Treatment of established osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1).  In post menopausal women a significant reduction in the incidence of vertebral and non-vertebral fractures, but not hip fractures has been demonstrated.

4.2          Posology and method of administration

Deletions in strikethrough text and added text in bold.

Children:  Forsteo has not been studied in paediatric populations.  Forsteo should not be used in paediatric patients or young adults with open epiphyses. There is no experience in children.  Forsteo should not be used in paediatric patients or young adults with open epiphyses.

4.3          Contra-indications

Changed text shown in bold.

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

4.8          Undesirable effects

Changed the way the frequency classification is expressed in all tables.

Changes to following statement shown in bold text.

The following convention has been used for the classification of the adverse reactions: very common (³1/10), common (³1/100 to<1/10), uncommon (³1/1,000 to <1/100), rare (³1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

5.             PHARMACOLOGICAL PROPERTIES

5.1          Pharmacodynamic properties

Added:

Independent risk factors, for example, low BMD, age, the existence of previous fracture, family history of hip fractures, high bone turnover and low body mass index should be considered in order to identify women and men at increased risk of osteoporotic fractures who could benefit from treatment.

Deletion shown in strikethrough text and added texts shown in bold.

Postmenopausal women: with established osteoporosis (T-score below -2.5 in the presence of one or more fragility fracture):

At baseline, ninety percent of the patients had one or more vertebral fractures and on average, vertebral BMD was 0.82 g/cm² (equivalent to a T-score = -2.6).  All patients were offered 1000mg calcium per day and at least 400IU vitamin D per day.  Results from up to 24 months (median: 19 months) treatment with Forsteo demonstrate statistically significant fracture reduction (Table 4).  To prevent one or more new vertebral fractures, 11 women had to be treated for a median of 19 months.

Changes to table shown in bold text:

Added text in bold

Male osteoporosis:

437 patients (mean age 58.7 years) were enrolled in a clinical trial for men with hypogonadal (defined as low morning free testosterone or an elevated FSH or LH) or idiopathic osteoporosis.  . Baseline spinal and femoral neck bone mineral density mean T-scores were -2.2 and -2.1, respectively.  At baseline, 35% of patients had a vertebral fracture and 59% had a non-vertebral fracture.

6.             PHARMACEUTICAL PARTICULARS

6.4          Special precautions for storage

Changed storage instruction from ‘Store at 2ºC-8°C at all times.’ to ‘Store in a refrigerator (2ºC-8°C) at all times.’.

6.6          Special precautions for disposal

Changed the title of 6.6 from ’Instructions for use and handling’ to the above and deleted the reference to Becton Dickson needles in this section.

Added:

Any unused product or waste material should be disposed of in accordance with local requirements.

9.             DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Added text in bold

Date of first authorisation: 10 June 2003

10.          DATE OF REVISION OF THE TEXT

New date

22 June 2007