Consumer medicine information

1. Why am I using Mytolac?

Mytolac contains the active ingredient lanreotide (as acetate). Mytolac is used for the:

• treatment of acromegaly when the circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy, or in patients who do not respond to therapy with medicines called dopamine agonists

• treatment of symptoms associated with carcinoid syndrome, such as flushing and diarrhoea

• treatment and control of the growth of some advanced tumours of the intestine and pancreas that cannot be removed by surgery (called gastroenteropancreatic neuroendocrine tumours or GEP-NETs) in adult patients.

2. What should I know before I use Mytolac?

Do not use if you have ever had an allergic reaction to lanreotide, somatostatin or medicines from the same family or any of the ingredients listed at the end of the CMI. Do not use Mytolac if you are breastfeeding.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Mytolac? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Mytolac and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Mytolac?

• Information on how to inject Mytolac can be found in the Instructions for administration of the product at the end of this leaflet.

• For the treatment of acromegaly or the symptoms of carcinoid syndrome, the recommended starting dose is 60 mg to 120 mg injected every 28 days.

• For the treatment of advanced tumours of the intestine and pancreas that cannot be removed by surgery (GEP-NETs), the recommended dose is 120 mg every 28 days.

5. What should I know while using Mytolac?

6. Are there any side effects?

More common side effects of Mytolac are related to the gastrointestinal tract and possible occurrence of gallstones. Serious side effects may be allergic reaction or gallstone complications.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Lanreotide acetate.

2 Qualitative and Quantitative Composition

Lanreotide (as acetate) 60 mg, 90 mg and 120 mg solution for injection in a pre-filled syringe.
Each pre-filled syringe contains a supersaturated solution of lanreotide acetate corresponding to 24.6 mg of lanreotide base per 100 mg of solution. Each syringe delivers an injection dose of 60 mg, 90 mg and 120 mg of lanreotide base, respectively.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection in a pre-filled syringe.
It is a white to pale-yellow semi-solid formulation and is formulated as a prolonged-release solution of lanreotide acetate for deep subcutaneous injection. Prolonged release of the peptide is achieved by the physical nature of the supersaturated solution.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 for Australia and National Poisons Centre on 0800 POISON (0800 764766) for New Zealand.
Animal data do not predict any effects other than those on insulin and glucagon secretion and the gastrointestinal system. If overdosage occurs, symptomatic management is indicated.
One spontaneous report of an overdose of a microparticle formulation of lanreotide was reported in a 52 year old patient, with a medical history of diabetes mellitus and hypertension, who had received as a result of drug misuse 30 mg lanreotide per day for 2 months. No acute symptoms or pharmacological signs of overdose were reported. The patient died of an acute myocardial infarction, one week after the last dose.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Lanreotide did not show mutagenic or clastogenic activity in a standard battery of in vitro and in vivo tests.
Carcinogenicity. Two carcinogenicity studies were conducted by the subcutaneous route in mice and rats at doses up to 30 and 0.5 mg/kg/day respectively. Lanreotide did not increase tumour incidences at doses up to 5 mg/kg/day in male mice and 1.5 mg/kg/day in female mice (relative exposure based on animal:human serum AUC, ≤ 12) and at 0.1 mg/kg/day in rats (relative exposure, ≤ 1). Injection site tumours (fibroma, fibrosarcoma and/or malignant fibrous histiocytoma) were increased in incidence at higher doses (relative exposure, ≥ 18 in mice and ≥ 2 in rats). The development of these tumours is consistent with chronic irritation/ inflammation in rodents from repeated injection and they are not considered to indicate a carcinogenic hazard to humans.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

The pH of Mytolac solution is 5.7 to 6.3.
Chemical structure. Lanreotide is a peptide containing eight amino acids as shown below:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLANACE.gif Molecular formula: C₅₄H₆₉N₁₁O₁₀S₂.
CAS number. 108736-35-2.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/MYTOLAST.gif