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Sandostatin 0.05mg/ml, 0.1 mg/ml, 0.5 mg/ml Ampoules and Multidose Vial 1 mg/5 ml

Last Updated on eMC 05-Jul-2012 View document  | Novartis Pharmaceuticals UK Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 05-Jul-2012 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 19-Jun-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4

The followin paragraph has been added as below:

Thyroid function (TSH and thyroid hormone levels) should be monitored in patients receiving long-term Sandostatin therapy.

 

Hepatic function should be monitored during octreotide therapy.


Section 4.6

Pregnancy

Sandostatin should only be prescribed to pregnant women under compelling circumstances (see also section 4.4 Special warnings and precautions for use).

 

There are no adequate and well-controlled studies in pregnant women.  In the post-marketing experience, data on a limited number of exposed pregnancies have been reported in patients with acromegaly, however, in half of the cases the pregnancy outcomes are unknown.  Most women were exposed to octreotide during the first trimester of pregnancy at doses ranging from 100-300 micrograms/day of Sandostatin s.c. or 20-30 mg/month of Sandostatin LAR.  In approximately two-thirds of the cases with known outcome, the women elected to continue octreotide therapy during their pregnancies.  In most of the cases with known outcome, normal newborns were reported, but also several spontaneous abortions during the first trimester, and a few induced abortions.

 

There were no cases of congenital anomalies or malformations due to octreotide usage in the cases that reported pregnancy outcomes.

 

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development apart from some transient retardation of physiological growth (see section 5.3 Preclinical safety data).

Studies in animals showed transient growth retardation of offspring, possibly consequent upon the specific endocrine profiles of the species tested, but there was no evidence of foetotoxic, teratogenic or other reproduction effects.


Lactation remains unchanged.

Updated on 26-Jun-2012 and displayed until 05-Jul-2012

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 08-Jun-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The following text has been added to Section 1:

Octreotide Ampoules 50 mcg/ml solution for injection or concentrate for solution for infusion

Octreotide Ampoules 100 mcg/ml solution for injection or concentrate for solution for infusion

Octreotide Ampoules 500 mcg/ml solution for injection or concentrate for solution for infusion

Octreotide Multidose Vial 1mg/5ml solution for injection or concentrate for solution for infusion.

Updated on 04-Mar-2010 and displayed until 26-Jun-2012

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use

Date of revision of text on the SPC: 18-Feb-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2:
The section on 'Use in patients with impaired hepatic function' was changed as follows:

Use in patients with impaired hepatic liver function

            In a study with Sandostatin administered s.c. and i.v. it was shown that the elimination capacity maybe reduced in patients with liver cirrhosis,  but not in patients with fatty liver disease. In patients with liver cirrhosis, an adjustment of the maintenance dose may therefore be necessary. In patients with liver cirrhosis, the half-life of the drug may be increased, necessitating adjustment of the maintenance dosage.

Section 4.4:
A new section on Local Site Reactions was added above Nutrition as follows:

            Local Site Reactions

In a 52-week toxicity study in rats, predominantly in males, sarcomas were noted at the s.c. injection site only at the highest dose (about 40 times the maximum human dose). No hyperplastic or neoplastic lesions occurred at the s.c. injection site in a 52-week dog toxicity study. There have been no reports of tumour formation at the injection sites in patients treated with Sandostatin for up to 15 years. All the information available at present indicates that the findings in rats are species specific and have no significance for the use of the drug in humans.

 

 

Updated on 12-Aug-2009 and displayed until 04-Mar-2010

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 05-Jun-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



 

Section 4.4 Special Warnings and Precautions for Use

 

Has been changed from :

 

General

As growth hormone secreting pituitary tumours may sometimes expand, causing serious complications (e.g. visual field defects), it is essential that all patients be carefully monitored. If evidence of tumour expansion appears, alternative procedures may be advisable.

 

Thyroid function should be monitored in patients receiving long-term Sandostatin therapy.

 

To:

 

General

As growth hormone secreting pituitary tumours may sometimes expand, causing serious complications (e.g. visual field defects), it is essential that all patients be carefully monitored. If evidence of tumour expansion appears, alternative procedures may be advisable.

 

The therapeutic benefits of a reduction in growth hormone (GH) levels and normalisation of insulin-like growth factor 1 (IGF-1) concentration in female acromegalic patients could potentially restore fertility.  Female patients of child bearing potential should be advised to use adequate contraception if necessary during treatment with octreotide (see also section 4.6 Pregnancy and lactation).

 

Thyroid function (TSH and thyroid hormone levels) should be monitored in patients receiving long-term Sandostatin therapy.

 

 

Section 4.6 Pregnancy and Lactation

 

Has been changed from:

 

Experience with octreotide in pregnant or nursing women is very limited, and they should therefore be given the drug only under compelling circumstances.

 

Women receiving treatment with Sandostatin should not breastfeed their infants.

 

To:

 

Pregnancy

Sandostatin should only be prescribed to pregnant women under compelling circumstances (see also section 4.4 Special warnings and precautions for use).

 

There are no adequate and well-controlled studies in pregnant women.  In the post-marketing experience, data on a limited number of exposed pregnancies have been reported in patients with acromegaly, however, in half of the cases the pregnancy outcomes are unknown.  Most women were exposed to octreotide during the first trimester of pregnancy at doses ranging from 100-300 micrograms/day of Sandostatin s.c. or 20-30 mg/month of Sandostatin LAR.  In approximately two-thirds of the cases with known outcome, the women elected to continue octreotide therapy during their pregnancies.  In  most of the cases with known outcome, normal newborns were reported, but also several spontaneous abortions during the first trimester, and a few induced abortions.

 

There were no cases of congenital anomalies or malformations due to octreotide usage in the cases that reported pregnancy outcomes.

 

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development apart from some transient retardation of physiological growth (see section 5.3 Preclinical safety data).

 

Lactation

Patients should not breastfeed during Sandostatin treatment. It is unknown whether octreotide is excreted in human breast milk.  Animal studies have shown excretion of octreotide in breast milk. 

 

 

Section 4.8 Undesirable Effects

 

Has been changed from:

 

The main side-effects are local injection site reactions and gastrointestinal reactions.

 

The most commonly reported adverse reactions in clinical trials with Sandostatin administration were diarrhoea, abdominal pain, flatulence and local injection site pain or irritation.

 

In rare instances, gastrointestinal side-effects may resemble acute intestinal obstruction with progressive abdominal distension, severe epigastric pain, abdominal tenderness and guarding.

 

Pain or a sensation of stinging, tingling or burning at the site of s.c. injection,

with redness and swelling, rarely lasting more than 15 minutes. Local discomfort may be reduced by allowing the solution to reach room temperature before injection.

 

The following adverse drug reactions, listed in Table 1, have been accumulated from clinical studies with octreotide and spontaneously reported adverse reactions:

 

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (³ 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), including isolated reports.  Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

 

Table 1

 

Immune system disorders

 

Rare:

Very rare:

Hypersensitivity, rash

Anaphylaxis

Endocrine disorders

 

Very rare:

Hypoglycaemia, hyperglycaemia

Cardiac disorders

 

Uncommon:

Bradycardia, tachycardia.

Respiratory disorders

Very rare:

 

Dyspnoea

Gastrointestinal disorders

 

Common:

Diarrhoea, abdominal pain, constipation, flatulence.

Rare:

Steatorroea, nausea, vomiting, abdominal bloating.

Very rare:

Acute pancreatitis, anorexia, loose stools.

Hepatobiliary disorders

 

Uncommon:

Cholecystitis

Rare:

Gallstones

Very rare:

Acute hepatitis without cholestasis, hyperbilirubinaemia, elevated alkaline phosphatase, gamma glutamyl transferase and transaminases.

Skin and subcutaneous tissue disorder

 

Uncommon:

Hair loss

General disorders and administration site

 

Common:

Local injection site pain, swelling and irritation.

 

Although measured faecal fat excretion may increase, there is no evidence to date that long-term treatment with octreotide has led to nutritional deficiency due to malabsorption. 

 

Occurrence of gastrointestinal side-effects may be reduced by avoiding meals around the time of octreotide administration, that is, by injecting between meals or on retiring to bed.

 

In rare instances, acute pancreatitis has been reported; generally, this effect is seen within the first hours or days of Sandostatin treatment and resolves on withdrawal of the drug.  In addition, cholelithiasis-induced pancreatitis has been reported for patients on long-term Sandostatin treatment.

 

There have been isolated cases of biliary colic following the abrupt withdrawal of the drug in acromegalic patients in whom biliary sludge or gallstones had developed.

 

Post-marketing

The following adverse drug reactions have been observed during post-marketing experience.  On rare occasions thyroid dysfunction has been reported both under and over activity.  In some cases dyspepsic signs have been reported in patients receiving octreotide acetate.

 

Symptoms and episodes of arrhythmia have been reported in patients receiving octreotide acetate.  Other ECG changes such as QT prolongation, axis shifts, early repolarisation, low voltage, R/S transition, early R wave progression, and non-specific ST-T wave changes, have been reported during octreotide acetate therapy.  The relationship of these events to octreotide acetate is however not established because many acromegalic and carcinoid patients have underlying cardiac diseases (see section 4.4 Special warnings and precautions for use).

 

 

To:

 

4.8.      Undesirable Effects

 

The most frequent adverse reactions reported during octreotide therapy include gastrointestinal  disorders, nervous system disorders, hepatobiliary disorders, and metabolism and nutritional disorders.

 

The most commonly reported adverse reactions in clinical trials with octreotide administration were diarrhoea, abdominal pain, nausea, flatulence, headache, cholelithiasis, hyperglycaemia and constipation. Other commonly reported adverse reactions were dizziness, localised pain, biliary sludge, thyroid dysfunction (e.g., decreased thyroid stimulating hormone [TSH], decreased Total T4, and decreased Free T4), loose stools, impaired glucose tolerance, vomiting, asthenia and hypoglycaemia.

 

In rare instances, gastrointestinal side-effects may resemble acute intestinal obstruction with progressive abdominal distension, severe epigastric pain, abdominal tenderness and guarding.

 

Pain or a sensation of stinging, tingling or burning at the site of s.c. injection, with redness and swelling, rarely lasting more than 15 minutes. Local discomfort may be reduced by allowing the solution to reach room temperature before injection.

 

Although measured faecal fat excretion may increase, there is no evidence to date that long-term treatment with octreotide has led to nutritional deficiency due to malabsorption. 

 

Occurrence of gastrointestinal side-effects may be reduced by avoiding meals around the time of octreotide administration, that is, by injecting between meals or on retiring to bed.

 

In rare instances, acute pancreatitis has been reported; generally, this effect is seen within the first hours or days of Sandostatin treatment and resolves on withdrawal of the drug.  In addition, cholelithiasis-induced pancreatitis has been reported for patients on long-term Sandostatin treatment.

 

There have been isolated cases of biliary colic following the abrupt withdrawal of the drug in acromegalic patients in whom biliary sludge or gallstones had developed.

 

In both acromegalic and carcinoid syndrome patients ECG changes were observed such as QT prolongation, axis shifts, early repolarisation, low voltage, R/S transition, early R wave progression, and non-specific ST-T wave changes.  The relationship of these events to octreotide acetate is not established because many of these patients have underlying cardiac diseases (see section 4.4 Special warnings and precautions for use).

 

The following adverse drug reactions, listed in Table 1, have been accumulated from clinical studies with octreotide:

 

Adverse drug reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥1/100, < 1/10); uncommon (³ 1/1,000, ≤1/100); rare (≥1/10,000, ≤1/1,000) very rare (≤ 1/10,000), including isolated reports.  Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

 

Table 1 - Adverse drug reactions reported in clinical studies

 

Endocrine disorders

 

Common:

Hypothyroidism, thyroid dysfunction (e.g., decreased TSH, decreased Total T4 and decreased Free T4).

Metabolism and nutrition disorders

 

Very common:

Common:

Uncommon:

Hyperglycaemia.

Hypoglycaemia, impaired glucose tolerance, anorexia.

Dehydration.

Cardiac disorders

 

Common:

Uncommon:

Bradycardia.

Tachycardia.

Respiratory disorders

Common:

 

Dyspnoea.

Gastrointestinal disorders

 

Very common:

Diarrhoea, abdominal pain, nausea, constipation, flatulence.

Common:

Dyspepsia, vomiting, abdominal bloating, steatorrhoea, loose stools, discolouration of faeces.

Nervous system disorders

Very common:

Common:

 

Headache.

Dizziness.

Hepatobiliary disorders

 

Very common:

Cholelithiasis

Common:

Cholecystitis, biliary sludge, hyperbilirubinaemia.

Skin and subcutaneous tissue disorder

 

Common:

 Pruritus, rash, alopecia.

General disorders and administration site

 

Very common:

Injection site localised pain.

Investigations

Common:

 

Elevated transaminase levels.

 

Post-marketing

Spontaneously reported adverse reactions presented in Table 2, are reported voluntarily and it is not always possible to reliably establish frequency or a causal relationship to drug exposure. 

 

 

 

Table 2 - Adverse drug reactions derived from spontaneous reports

 

Immune disorders

Anaphylaxis, allergy/hypersensitivity reactions.

Skin and subcutaneous tissue disorders

 

Urticaria.

Hepatobiliary disorders

 

Acute pancreatitis, acute hepatitis without cholestasis, cholestatic hepatitis, cholestasis, jaundice, cholestatic jaundice.

Cardiac disorders

 

Arrhythmias.

 

Investigations

 

Increased alkaline phosphatase levels, increased gamma glutamyl transferase levels.

 

 

 

10.       DATE OF (PARTIAL) REVISION OF THE TEXT

 

Changed from 23 Feb 09  to  05 June 2009

 

 

 

 

 

 

 

 

 

 

 

 

 

Updated on 27-Mar-2009 and displayed until 12-Aug-2009

Reasons for adding or updating:

  • Change to section 4.9 - Overdose

Date of revision of text on the SPC: 23-Feb-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.9 has changed from:

 

4.9.      Overdose

 

Doses of up to 2000 microgrammes octreotide given as subcutaneous tid for several months have been well tolerated.

 

No life-threatening reactions have been reported after acute overdosage.  The maximum single dose so far given to an adult so far has been 1 mg by intravenous bolus injection.  The observed signs and symptoms were a brief drop in heart rate, facial flushing, abdominal cramps, diarrhoea, an empty feeling in the stomach and nausea, which resolved in 24 hours of drug administration.

 

One patient has been reported to have received an accidental overdosage of Sandostatin by continuous infusion (250 microgrammes per hour for forty eight hours instead of 25 microgrammes per hour).  He experienced no side-effects.

 

The management of overdosage is symptomatic.

 

 

To:

 

 

4.9.      Overdose

 

A limited number of accidental overdoses of Sandostatin in adults and children have been reported.  In adults, the doses ranged from 2400-6000 micrograms/day administered by continuous infusion (100-250 micrograms/hour) or subcutaneously (1500 micrograms t.i.d.).  The adverse events reported were arrhythmia, hypotension, cardiac arrest, brain hypoxia, pancreatitis, hepatitis steatosis, diarrhoea, weakness, lethargy, weight loss, hepatomegaly and lactic acidosis.

 

In children, the doses ranged from 50-3000 micrograms/day administered by continuous infusion (2.1-500 micrograms/hour) or subcutaneously (50-100 micrograms).  The only adverse event reported was mild hyperglycaemia.

 

No unexpected adverse events have been reported in cancer patients receiving Sandostatin at doses of 3000-30,000 micrograms/day in divided doses subcutaneously.

 

The management of overdosage is symptomatic.

 

 

Updated on 31-Oct-2008 and displayed until 27-Mar-2009

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Date of revision of text on the SPC: 19-Sep-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Shelf life decreased from 5 to 3 years

Updated on 01-Sep-2008 and displayed until 31-Oct-2008

Reasons for adding or updating:

  • Change to section 3 - Pharmaceutical form
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 06-May-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



SECTION 2

 

The following text has been added:

 

Sandostatin solution for injection contains less than 1mmol (23mg) sodium per dose, i.e essentially “sodium-free”.

 

SECTION 3

 

The following text has been added:

 

The solution is clear and colourless.

 

SECTION 6.6

 

The following text has been added:

 
Special precautions for disposal

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

 

SECTION 10

 

Date of revision changed from 24 October 2007 to 06 May 2008

Updated on 28-Nov-2007 and displayed until 01-Sep-2008

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 01-Oct-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update various sections of the SmPC, including updated information from post marketing data and clinical trials and reformatting.

Updated on 23-Dec-2004 and displayed until 28-Nov-2007

Reasons for adding or updating:

  • Change to section 9 - Date of Renewal of Authorisation

Updated on 01-Oct-2004 and displayed until 23-Dec-2004

Reasons for adding or updating:

  • Improved Electronic Presentation

Updated on 26-Feb-2003 and displayed until 01-Oct-2004

Reasons for adding or updating:

  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects

Updated on 21-Aug-2001 and displayed until 26-Feb-2003

Reasons for adding or updating:

  • Transferred from eMC version 1

Updated on 04-Jan-2001 and displayed until 21-Aug-2001

Reasons for adding or updating:

  • No reasons supplied

Updated on 06-Sep-1999 and displayed until 04-Jan-2001

Reasons for adding or updating:

  • No reasons supplied

Company contact details

Novartis Pharmaceuticals UK Ltd

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Address

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

Fax

+44 (0)1276 698 449

Medical Information e-mail
Telephone

+44 (0)1276 692 255

Medical Information Direct Line

+44 (0)1276 698 370

Customer Care direct line

+44 (0)845 741 9442

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Active ingredients

octreotide acetate

Legal categories

POM - Prescription Only Medicine

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