Consumer medicine information

1. Why am I using Fingolimod Sandoz?

Fingolimod Sandoz contains the active ingredient fingolimod hydrochloride. Fingolimod Sandoz is used to treat relapsing forms of multiple sclerosis in adults, children and adolescents (10 years of age and above). For more information, see Section 1. Why am I using Fingolimod Sandoz? in the full CMI.

2. What should I know before I use Fingolimod Sandoz?

Do not use if you have ever had an allergic reaction to fingolimod hydrochloride or any of the ingredients listed at the end of the CMI. 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 Fingolimod Sandoz? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Fingolimod Sandoz 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 Fingolimod Sandoz?

Adults: The usual dose is one 0.5 mg capsule taken once a day. Children and adolescents: The dose is dependent on body weight. More instructions can be found in Section 4. How do I use Fingolimod Sandoz? in the full CMI.

5. What should I know while using Fingolimod Sandoz?

6. Are there any side effects?

Common side effects: flu symptoms, headache, diarrhoea. Serious side effects: coughing with phlegm, chest pain, shingles/ herpes zoster, slow or irregular heartbeat, blurred vision, skin nodules. 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

The active ingredient of Fingolimod Sandoz is fingolimod.

2 Qualitative and Quantitative Composition

Fingolimod hydrochloride is a white to almost white crystalline powder which is freely soluble in water. Fingolimod is a base with pKa of 7.82. Therefore, it has high solubility at low pH and very low solubility at high pH (e.g. < 0.01 mg/mL at pH 6.8). Relevant distribution coefficients are 22.3 in n-Octanol/water and 1290 in n-Octanol/hydrochloric acid 0.1 N.
0.25 mg hard capsules. Each Fingolimod Sandoz capsule contains 0.28 mg fingolimod hydrochloride (equivalent to 0.25 mg fingolimod), mannitol, hyprolose, hydroxypropylbetadex, magnesium stearate, gelatin, titanium dioxide and iron oxide yellow.
0.5 mg hard capsules. Each Fingolimod Sandoz capsule contains 0.56 mg fingolimod hydrochloride (equivalent to 0.5 mg fingolimod), mannitol, magnesium stearate, titanium dioxide, iron oxide yellow and gelatin.
Excipients with known effect. Gelatin may contain residual sulfites.

3 Pharmaceutical Form

Fingolimod Sandoz 0.25 mg capsule. White to almost white powder in ivory opaque (body and cap), size 3, with black radial imprint "FTY 0.25 mg" on cap and black radial band on body.
Fingolimod Sandoz 0.5 mg capsule. White to almost white powder in white opaque body and bright yellow opaque cap gelatin capsules, size 3, radial imprint with black ink "FTY 0.5 mg" on cap and two radial bands imprinted on body with yellow ink.

4 Clinical Particulars

4.9 Overdose

No cases of overdosage have been reported. However, single doses up to 80-fold the recommended dose (0.5 mg) were well tolerated in healthy adult volunteers. At 40 mg, 5 of 6 subjects reported mild chest tightness or discomfort which was clinically consistent with small airway reactivity.
Fingolimod can induce bradycardia (see Section 5.1 Pharmacodynamic Properties, Pharmacodynamics, Heart rate and rhythm). Some patients experience mild to moderate symptoms, including hypotension, dizziness, fatigue, and/or palpitations. There have been reports of slow atrioventricular conduction with isolated reports of transient, spontaneously resolving complete A-V block (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).
If the overdose constitutes first exposure to fingolimod it is important to observe for signs and symptoms of bradycardia, which could include overnight monitoring. Regular measurements of pulse rate and blood pressure are required and electrocardiograms should be performed (see Section 4.2 Dose and Method of Administration; Section 4.4 Special Warnings and Precautions for Use).
Neither dialysis nor plasma exchange would result in meaningful removal of fingolimod from the body.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Fingolimod induced numerical chromosomal aberrations (polyploidy) in Chinese hamster cells at concentrations more than three orders of magnitude greater than the clinical steady-state plasma levels, but not in human lymphocytes when tested at similar concentrations. Fingolimod was not clastogenic in the in vivo micronucleus tests in mice and rats at exposures at least 500 times that expected clinically.
Carcinogenicity. In a 2-year mouse study, an increased incidence of malignant lymphoma was seen at oral doses of fingolimod of 0.25 mg/kg/day and higher, with exposure (plasma AUC) 5-fold the human systemic exposure at a daily dose of 0.5 mg. Exposure at the NOEL (0.025 mg/kg/day) was 0.6-fold human exposure. No evidence of carcinogenicity was observed in a 2-year bioassay in rats at oral doses of fingolimod up to the maximum tolerated dose of 2.5 mg/kg/day, representing a 50-fold margin based on the human systemic exposure (AUC) at the 0.5 mg dose.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical name: 2-amino-2-[2- (4-octylphenyl)ethyl]propan-1,3-diol hydrochloride.
Molecular formula: C₁₉H₃₃NO₂.HCl.
Molecular weight: 343.93.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFINHYD.gif CAS number. 162359-56-0.

7 Medicine Schedule (Poisons Standard)

Poison Schedule: S4.

Summary Table of Changes

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