Mycamine

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Micafungin 100 mg
Available from:
Seqirus (NZ) Ltd
INN (International Name):
Micafungin 100 mg
Dosage:
100 mg
Pharmaceutical form:
Powder for injection
Composition:
Active: Micafungin 100 mg Excipient: Citric acid Lactose Nitrogen Sodium hydroxide
Prescription type:
Prescription
Manufactured by:
Astellas Pharma Tech Co Limited
Therapeutic indications:
Treatment of invasive candidiasis in children & adults Treatment of oesophageal candidiasis in adults, adolescents NLT 16 yrs of age, and elderly patients for whom intravenous therapy is appropriate Prophylaxis of Candida infection in children and adult patients undergoing allogenic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count below 500 cells per microliter) for 10 or more days
Product summary:
Package - Contents - Shelf Life: Vial, glass, 1 x - 100 mg - 3 years from date of manufacture stored at or below 25°C 48 hours reconstituted stored at or below 25°C 96 hours diluted stored at or below 25°C protect from light - Vial, glass, 10 x - 1000 mg - 3 years from date of manufacture stored at or below 25°C 48 hours reconstituted stored at or below 25°C 96 hours diluted stored at or below 25°C protect from light
Authorization number:
TT50-9435a
Authorization date:
2013-11-14

Read the complete document

Mycamine

Mycamine

Micafungin (as sodium)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Mycamine.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits

Your doctor has weighed

the risks of you having Mycamine

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet

You may need to read it again.

What Mycamine is used

for

This medicine is used to treat:

adults, adolescents and children

who have a serious fungal

infection called invasive

candidiasis (an infection caused

by a yeast called

Candida

that

has penetrated the body)

adults and adolescents ≥

16 years of age who have a

fungal infection in the food pipe

(oesophagus) where treatment

into a vein is appropriate

adults, adolescents and children

who are at risk of developing a

Candida

(yeast) infection while

undergoing a certain type of

stem cell transplant or if you are

expected to have white blood

cell counts below a certain level.

This medicine belongs to a group

of medicines called echinocandins

which are used to treat infections

caused by fungal or yeast cells

called Candida.

It works by interfering with the

production of a part of the fungal

cell wall making the fungus unable

to live and grow.

Ask your doctor if you have any

questions about why this

medicine has been prescribed for

you.

Your doctor may have prescribed it

for another reason

Before you are given

Mycamine

When you must not have it

Do not have Mycamine if you

have an allergy to:

any medicine containing

micafungin

any of the ingredients listed at

the end of this leaflet

any other medicines belonging

to the echinocandin group.

Some of the symptoms of an

allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin

Do not have this medicine after

the expiry date printed on the

pack or if the packaging is torn

or shows signs of tampering.

If you are not sure whether you

should start having this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

haemolytic anaemia (anaemia

due to breakdown of red blood

cells) or haemolysis (breakdown

of red blood cells)

kidney problems such as kidney

failure or an abnormal kidney

function test

liver problems such as liver

failure, hepatitis or abnormal

liver function tests.

Tell your doctor if you are

pregnant or plan to become

pregnant or are breast-feeding.

Your doctor can discuss with you

the risks and benefits involved.

If you have not told your doctor

about any of the above, tell

him/her before you start

receiving Mycamine.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and Mycamine

may interfere with each other.

These include:

itraconazole, medicines used to

treat fungal infections

sirolimus, a medicine used to

prevent kidney transplant

rejection

nifedipine, a medicine used to

treat high blood pressure.

Mycamine

These medicines may be affected

by Mycamine. You may need

different

amounts of these

medicines, or you may need to take

different medicines.

Your doctor and pharmacist have

more information on medicines to

be careful with or avoid while

receiving this medicine.

How Mycamine is given

This medicine must be prepared

and given to you in the hospital by

a nurse or another health care

professional.

How much you will be given

Your doctor will decide how much

Mycamine you will receive each

.

For adults, adolescents ≥ 16 years

of age:

the usual dose to treat an

invasive

Candida

infection is

100 mg per day for patients

weighing more than 40 kg, and

2 mg/kg per day for patients

weighing 40 kg or less

the dose to treat a

Candida

infection of the oesophagus is

150 mg for patients weighing

more than 40 kg and 3 mg/kg

per day for patients weighing

40 kg or less

the usual dose for patients at

risk of developing a

Candida

infection is 50 mg per day for

patients weighing more than

40 kg and 1 mg/kg per day for

patients weighing 40 kg or less.

For children (including newborns)

and adolescents < 16 years of age:

the usual dose to treat an

invasive

Candida

infection is

100 mg per day for patients

weighing more than 40 kg, and

2 mg/kg per day for patients

weighing 40 kg or less

the usual dose for patients at

risk of developing a

Candida

infection is 50 mg per day for

patients weighing more than

40 kg and 1 mg/kg per day for

patients weighing 40 kg or less.

When it will be given

This medicine is given once daily

by a slow infusion into a vein. The

infusion usually lasts one hour.

How long will you be given it

For the treatment of an invasive

Candida

infection, you will usually

receive this medicine for at least

14 days but treatment will usually

continue for at least one week after

symptoms and blood results show

the infection has been cleared.

For a

Candida

infection of the

oesophagus, treatment will usually

continue for at least one week after

symptoms have disappeared.

For the prevention of

Candida

infection, treatment will usually

continue for at least one week after

white blood cell numbers are back

to normal.

If you miss a dose

Your doctor monitors your

response and condition to

determine how long treatment is

needed. However, if you are

concerned that you may have

missed a dose, speak to your doctor

or another health care professional

immediately.

If you are given too much

(overdose)

Your doctor monitors your

response and condition to

determine what dose is needed.

However, if you are concerned that

you may have been given too much

Mycamine, speak to your doctor or

another health care professional

immediately.

While you are receiving

Mycamine

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are receiving Mycamine.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are having this

medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist

that you are having this

medicine.

It may affect other medicines used

during surgery.

If you become pregnant while

receiving this medicine, tell your

doctor immediately.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are receiving

Mycamine.

This medicine helps most people

with prevention or treatment of

fungal infections but it may have

unwanted side effects in a few

people. All medicines can have

side effects. Sometimes they are

serious, most of the time they are

not. You may need medical

attention if you get some of the side

effects.

Do not be alarmed by the

following lists of side effects. You

may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following

and they worry you:

Diarrhoea

Nausea or vomiting

Mycamine

Constipation

Fever or high temperature

Headache

Stomach pain or discomfort

Indigestion

Tiredness

Loss of appetite

Joint or back pain

Difficulty sleeping

Cough.

Tell your doctor as soon as

possible if you notice any of the

following:

Swelling of the hands, ankles or

feet

Shortness of breath or difficulty

breathing

Rash, itchiness or hives

Fast heartbeat or changes in the

way the heart beats

Difficulty passing urine

Yellowing of the skin or eyes.

The above list includes serious side

effects that may require medical

attention.

Tell your doctor or pharmacist if

you notice anything that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

Some of these side effects (for

example, changes in blood test

results or blood pressure) can only

be found when your doctor does

tests from time to time to check

your progress.

After receiving

Mycamine

Storage

Unopened vials should be kept in a

cool dry place where the

temperature stays below 25

The prepared infusion solution

should be used immediately and

kept protected from light. If the

infusion solution appears cloudy, it

should not be used.

Product description

What it looks like

Mycamine 50 mg is a white

coloured powder for injection

contained within a glass vial with a

rubber stopper, blue flip off cap and

UV protective shrink wrapping

film.

Mycamine 100 mg is a white

coloured powder for injection

contained within a glass vial with a

rubber stopper, red flip off cap and

UV protective shrink wrapping

film.

Both strengths are available in

packs of 1 or 10 vials.

Ingredients

Mycamine contains 50 mg or

100 mg of micafungin (as sodium)

as the active ingredient.

Each vial also contains:

lactose

anhydrous citric acid

sodium hydroxide.

This medicine does not contain,

sucrose, gluten, tartrazine or any

other azo dyes.

Supplier

Mycamine is distributed in New

Zealand by:

bioCSL (NZ) Ltd

PO Box 62 590

Greenlane, Auckland, 1546

New Zealand

= Registered Trademark

Australian registration numbers:

50 mg - AUST R 196108

100 mg - AUST R 196109

This leaflet was prepared in May

2014

.

Read the complete document

DATA SHEET

MYCAMINE

®

50 mg and 100 mg POWDER FOR INJECTION

1.

NAME OF THE MEDICINE

MYCAMINE

50 mg powder for injection

MYCAMINE

100 mg powder for injection

Active ingredient:

micafungin (as sodium)

Chemical structure:

Chemical name:

Sodium 5-[(1

S

S

)-2-[(3

S

S

S

R

S

S

R

R

S

S

S

)-3-

R

)-2-carbamoyl-1-hydroxyethyl]-11,20,21,25-tetrahydroxy-15-[(

R

)-1-

hydroxyethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-18-[4-[5-(4-pentyloxyphenyl)-

isoxazol-3-yl]benzoylamino]-1,4,7,13,16,22-hexaazatricyclo-[22.3.0.0

9,13

]heptacos-6-yl]-1,2-

dihydroxyethyl]-2-hydroxyphenyl sulfate.

Molecular formula:

CAS registry number:

208538-73-2

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

MYCAMINE is a sterile, white, powder for injection containing the active ingredient

micafungin as the sodium salt. Micafungin sodium is a light sensitive, hygroscopic, amorphous,

white powder that is freely soluble in water, isotonic sodium chloride solution,

N,N

dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically

insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and

n

-hexane.

MYCAMINE must be diluted with either sodium chloride 0.9% or glucose 5% solution prior to

use (see DOSAGE AND ADMINISTRATION).

3.

PHARMACEUTICAL FORM

MYCAMINE 50 mg is a white-coloured powder for injection, containing 50.86 mg micafungin

sodium, corresponding to 50 mg micafungin.

MYCAMINE 100 mg is a white-coloured powder for injection, containing 101.73 mg

micafungin sodium, corresponding to 100 mg micafungin.

4.

CLINICAL PARTICULARS

4.1

Therapeutic Indication

MYCAMINE is indicated for:

Treatment of invasive candidiasis in children and adults

Treatment of oesophageal candidiasis in adults, adolescents ≥ 16 years of age and the

elderly patients for whom intravenous therapy is appropriate

Prophylaxis of Candida infection in children and adult patients undergoing allogeneic

haematopoietic stem cell transplantation or patients who are expected to have

neutropenia (absolute neutrophil count < 500 cells/µL) for 10 or more days

4.2

Dose and method of administration

MYCAMINE should be administered once daily by intravenous infusion. The dosage depends

on the indication and the body-weight of the patient as shown in Tables 1 and 2 below.

Table 1. Dosage for adults, adolescents ≥ 16 years of age, and the elderly

Indication

Body-weight > 40 kg

Body-weight ≤ 40 kg

Treatment of invasive candidiasis

100 mg/day*

2 mg/kg/day*

Treatment of oesophageal candidiasis

150 mg/day

3 mg/kg/day

Prophylaxis of

Candida

infection

50 mg/day

1 mg/kg/day

*

If the patient’s response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, the

dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients weighing ≤ 40 kg.

Treatment duration

Invasive candidiasis:

The treatment duration for

Candida

infection should be a minimum of 14

days. The antifungal treatment should continue for at least 1 week after two sequential negative

blood cultures have been obtained and after resolution of clinical signs and symptoms of

infection.

Oesophageal candidiasis:

For the treatment of oesophageal candidiasis, MYCAMINE should

be administered for at least 1 week after resolution of clinical signs and symptoms.

Prophylaxis of Candida infections:

For prophylaxis of

Candida

infection, MYCAMINE should

be administered for at least 1 week after neutrophil recovery.

Table 2. Dosage for children (including neonates) and adolescents < 16 years of age

Indication

Body-weight > 40 kg

Body-weight ≤ 40 kg

Treatment of invasive candidiasis

100 mg/day*

2 mg/kg/day*

Prophylaxis of

Candida

infection

50 mg/day

1 mg/kg/day

*

If the patient’s response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, the

dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients weighing ≤ 40 kg.

Treatment duration

Invasive candidiasis:

The treatment duration for

Candida

infection should be a minimum of 14

days and should continue for at least 1 week after two sequential negative blood cultures have

been obtained and after resolution of clinical signs and symptoms of infection.

Prophylaxis of Candida infections:

For prophylaxis of

Candida

infection, MYCAMINE should

be administered for at least 1 week after neutrophil recovery. Experience in patients less than

two years of age is limited.

Patients with hepatic impairment

No dosage adjustment is required in patients with mild to severe hepatic impairment (see

PHARMACOLOGY, Pharmacokinetic characteristics in special populations).

Patients with renal impairment

No dosage adjustment is required in patients with severe renal impairment (creatinine clearance

< 30 mL/min) (see PHARMACOLOGY, Pharmacokinetic characteristics in special

populations).

Administration

An existing intravenous line should be flushed with sodium chloride 0.9% solution prior to

infusion. Administer the reconstituted and diluted MYCAMINE solution intravenously over

approximately 1 hour.

4.3

Contraindications

MYCAMINE is contraindicated in patients with hypersensitivity to any component of this

medication or to other echinocandins (see QUALITATIVE AND QUANTITATIVE

COMPOSITION).

4.4

Special warnings and precautions for use

Hypersensitivity

During administration of micafungin, anaphylactic/anaphylactoid reactions including shock

may occur. If these reactions occur, MYCAMINE should be discontinued and appropriate

treatment administered.

Skin and Subcutaneous Tissue Disorders

Exfoliative cutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal

necrolysis have been reported. If patients develop a rash, they should be monitored closely and

MYCAMINE discontinued if lesions progress.

Haemolysis

Isolated cases of haemolysis, including acute intravascular haemolysis or haemolytic anaemia,

have been reported in patients treated with micafungin. Patients who develop clinical or

laboratory evidence of haemolysis during MYCAMINE therapy should be monitored closely

for evidence of worsening of these conditions and evaluated for the risk/benefit of continuing

therapy.

Hepatic effects

Liver function should be carefully monitored during MYCAMINE treatment. Early

discontinuation in the presence of significant and persistent elevation of ALT/AST is

recommended. MYCAMINE treatment should be conducted on a careful risk/benefit basis,

particularly in patients having severe liver function impairment or chronic liver diseases known

to represent preneoplastic conditions, such as advanced liver fibrosis, cirrhosis, viral hepatitis,

neonatal liver disease or congenital enzyme defects, or receiving a concomitant therapy

including hepatotoxic and/or genotoxic properties.

Paediatric use

No dosage adjustment is necessary for children (see PHARMACOLOGY, Pharmacokinetic

characteristics in special populations). However, the incidence of some adverse reactions was

higher in paediatric patients than in adult patients (see ADVERSE EVENTS).

Use in the elderly

No dosage adjustment is necessary for the elderly (see PHARMACOLOGY, Pharmacokinetic

characteristics in special populations).

Effect on laboratory tests

There is no information on the effect of micafungin on laboratory tests.

4.5

Interaction with other medicines and other forms of interaction

Micafungin has a low potential for interactions with medicines metabolised via CYP3A-

mediated pathways as shown below.

Effects of other medicines on micafungin

A total of 14 drug-drug interaction studies were conducted in healthy volunteers to evaluate the

potential for interaction between micafungin and mycophenolate mofetil, cyclosporin,

tacrolimus, prednisolone, sirolimus, nifedipine, fluconazole, ritonavir, rifampicin, itraconazole,

voriconazole and amphotericin B. In these studies, no interaction that altered the

pharmacokinetics of micafungin was observed. Therefore, no MYCAMINE dose adjustments

are necessary when these medicines are administered concomitantly.

Effects of micafungin on other medicines

There was no effect of a single dose or multiple doses of micafungin on mycophenolate

mofetil, cyclosporin, tacrolimus, prednisolone, fluconazole and voriconazole pharmacokinetics.

Sirolimus AUC was increased by 21% with no effect on C

in the presence of steady-state

micafungin compared with sirolimus alone. Nifedipine AUC and C

were increased by 18%

and 42% respectively, in the presence of steady-state micafungin compared with nifedipine

alone. Itraconazole AUC and C

were increased by 22% and 11% respectively. Therefore,

patients receiving sirolimus, nifedipine or itraconazole in combination with MYCAMINE

should be monitored for toxicity and the dosage of sirolimus, nifedipine or itraconazole reduced

if necessary.

4.6

Fertility, Pregnancy and Lactation

Effects on fertility

Micafungin had no effect on the fertility of male and female rats at doses up to 32 mg/kg/day

IV (four times the anticipated maximum clinical exposure, based on AUC). However, male

rats treated for 9 weeks at 10–32 mg/kg/day IV micafungin (resulting in 1–4-fold the

anticipated maximum clinical exposure, based on AUC) showed vacuolation of the epididymal

ductal epithelial cells. A dose of 32 mg/kg/day also resulted in higher epididymis weights and

reduced numbers of sperm cells. In a 39-week IV study in dogs, seminiferous tubular atrophy

and decreased sperm in the epididymis were also observed at 10 and 32 mg/kg/day IV

micafungin (resulting in 1–5-fold the anticipated maximum clinical exposure, based on AUC).

Testicular toxicity was observed in two animal species. Although the clinical relevance is

unknown, micafungin may have the potential to affect male fertility in humans.

Use in pregnancy (Category B3

There are no adequate and well-controlled studies of micafungin in pregnant women.

Micafungin and/or its metabolites were shown to cross the placental barrier and distribute to the

foetus in rats. No effects on embryo foetal development were observed in rats given IV doses

of micafungin up to 32 mg/kg/day throughout organogenesis (2–3-fold the anticipated

maximum clinical exposure, based on AUC). However, treatment of rabbits at doses of

32 mg/kg/day IV (twice the maximum anticipated clinical exposure, based on AUC) throughout

organogenesis was associated with visceral abnormalities and increased abortion. Visceral

abnormalities included abnormal lobation of the lung, levocardia, retrocaval ureter, anomalous

right subclavian artery, and dilation of the ureter.

While animal studies are not always predictive of a human response, MYCAMINE should only

be used during pregnancy if the potential benefit justifies the potential risk to the foetus.

Use in lactation

Micafungin and its metabolites were excreted in the milk of lactating rats. In a pre- and

postnatal development study in rats, doses of 32 mg/kg/day IV micafungin (resulting in 2–3-

fold the anticipated maximum clinical exposure, based on AUC) were associated with reduced

pup birth-weights and a possible delay in the time of eyelid opening and balanopreputia

cleavage.

It is not known whether micafungin is excreted in human breast-milk. Therefore caution

should be exercised when MYCAMINE is administered during breastfeeding.

4.7

Effects on ability to drive and use machines

Micafungin has no or negligible influence on the ability to drive or use machines.

4.8

Undesirable Effects

Overall Mycamine Safety Experience in Clinical Trials

The overall safety of MYCAMINE was assessed in 3083 patients and 501 volunteers in 41

clinical studies, including the invasive candidiasis, oesophageal candidiasis and prophylaxis

Drugs which have been taken by only a limited number of pregnant women and women of childbearing age,

without an increase in the frequency of malformation or other direct or indirect harmful effects on the human

foetus having been observed. Studies in animals have shown evidence of an increased occurrence of foetal

damage, the significance of which is considered uncertain in humans.

studies, who received single or multiple doses of MYCAMINE, ranging from 12.5 mg to

≥ 150 mg/day. Treatment emergent adverse events which occurred in ≥ 5% of all patients who

received MYCAMINE in these trials are shown in Table 3.

Overall, 2810 of 3083 (91.1%) patients who received MYCAMINE experienced an adverse

event.

Clinically significant adverse events regardless of causality or incidence which occurred in these

trials are listed below:

Blood and lymphatic system disorders

: coagulopathy, febrile neutropenia, haemolysis,

haemolytic anaemia, pancytopenia, thrombotic thrombocytopenic purpura

Cardiac disorders

: arrhythmia, atrial fibrillation, cardiac arrest, cyanosis, hypotension,

myocardial infarction, tachycardia

Gastrointestinal disorders

: abdominal pain upper, dyspepsia

General disorders and administration site conditions

: injection site thrombosis

Hepatobiliary disorders

: hepatocellular damage, hepatomegaly, jaundice, hepatic failure

Infections and infestations

: infection, pneumonia, sepsis

Metabolism and nutrition disorders

: acidosis, anorexia, hyponatraemia

Musculoskeletal, connective tissue and bone disorders

: arthralgia

Nervous system disorders

: convulsions, encephalopathy, intracranial haemorrhage

Psychiatric disorders

: delirium

Renal and urinary disorders

: anuria, haemoglobinuria, oliguria, renal failure acute, renal

tubular necrosis

Respiratory, thoracic and mediastinal disorders

: apnoea, dyspnoea, hypoxia, pulmonary

embolism

Skin and subcutaneous tissue disorders

: erythema multiforme, skin necrosis, urticaria

Vascular disorders

: deep venous thrombosis, hypertension

Table 3. *Adverse Events in Patients Who Received Mycamine in Clinical Trials

Adverse Events

(MedDRA System Organ Class and Preferred Term)

Mycamine

n (%)

Number of Patients

3083

All Systems, Any Adverse Event

2810 (91.1)

Gastrointestinal Disorders

1764 (57.2)

Diarrhoea NOS

718 (23.3)

Nausea

679 (22)

Vomiting NOS

669 (21.7)

Constipation

341 (11.1)

Abdominal Pain

300 (9.7)

Dyspepsia

176 (5.7)

General

Disorders

/

Administration

Site

Conditions

1407 (45.6)

Pyrexia

618 (20)

Mucosal Inflammation NOS

438 (14.2)

Rigors

281 (9.1)

Oedema Peripheral

209 (6.8)

Fatigue

198 (6.4)

Metabolism and Nutrition Disorders

1316 (42.7)

Hypokalaemia

556 (18)

Hypomagnesaemia

409 (13.3)

Hypocalcaemia

201 (6.5)

Anorexia

190 (6.2)

Hyperglycaemia NOS

173 (5.6)

Fluid Overload

155 (5)

Infections and Infestations

1227 (39.8)

Bacteraemia

185 (6)

Sepsis NOS

156 (5.1)

Respiratory, Thoracic and Mediastinal Disorders

1108 (35.9)

Cough

251 (8.1)

Dyspnoea NOS

182 (5.9)

Epistaxis

172 (5.6)

Blood and Lymphatic System Disorders

1047 (34)

Thrombocytopenia

474 (15.4)

Neutropenia

436 ( 14.1)

Anaemia NOS

302 (9.8)

Febrile Neutropenia

187 (6.1)

Investigations

989 (32.1)

Aspartate Aminotransferase Increased

172 (5.6)

Blood Alkaline Phosphatase NOS Increased

168 (5.4)

Alanine Aminotransferase Increased

165 (5.4)

Skin and Subcutaneous Tissue Disorders

940 (30.5)

Rash NOS

269 (8.7)

Pruritus NOS

187 (6.1)

Nervous System Disorders

889 (28.8)

Headache NOS

489 (15.9)

Psychiatric Disorders

727 (23.6)

Insomnia

303 (9.8)

Anxiety

198 (6.4)

Vascular Disorders

867 (28.1)

Hypotension NOS

279 (9.1)

Hypertension NOS

214 (6.9)

Phlebitis NOS

172 (5.6)

Musculoskeletal and Connective Tissue Disorders

579 (18.8)

Back Pain

166 (5.4)

Cardiac Disorders

563 (18.3)

Tachycardia NOS

231 (7.5)

Patient base: all randomised patients who received at least one dose of trial drug

Common: Incidence of adverse event ≥ 5%

* During treatment + 3 days

† Within a system organ class patients may experience more than one adverse event

Post-marketing Adverse Reactions

The following adverse reactions have been identified during the post-approval use of

micafungin (as sodium) powder for injection. Because these reactions are reported voluntarily

from a population of uncertain size, it is not always possible to reliably estimate their

frequency. A causal relationship to micafungin (as sodium) powder for injection could not be

excluded for these adverse reactions, which included:

Blood and lymphatic system disorders

: white blood cell count decreased, haemolytic

anaemia, disseminated intravascular coagulation

Hepatobiliary disorders:

hyperbilirubinaemia, hepatic function abnormal, hepatic disorder,

hepatocellular damage

Renal and urinary disorders

: acute renal failure and renal impairment

Skin and subcutaneous tissue disorders

: Stevens-Johnson syndrome, toxic epidermal

necrolysis

Vascular disorders

: shock

Paediatric patients

The incidence of some adverse events (AEs) in the clinical study database (thrombocytopenia,

tachycardia, hypertension, hypotension, hyperbilirubinaemia, hepatomegaly, renal failure acute,

blood urea increased) was higher in children than in adult patients. Additionally, paediatric

patients < 1 year of age experienced about twice as often an increase in ALT, AST and AP than

older paediatric patients. No clinically meaningful differences in the safety profile could be

discerned by paediatric age strata of < 4 weeks, 4 weeks to < 1 year, 1 to 4 years, 5 to 8 years, 9

to 12 years and 13 to < 16 years.

4.9

Overdose

For information on the management of overdose, contact the National Poisons Centre on 0800

POISON (0800 764 766).

There is no experience with overdoses of micafungin. In case of overdose, general supportive

measures and symptomatic treatment should be administered. Micafungin is highly protein

bound and is therefore not dialysable.

Repeated daily doses of up to 4 mg/kg (median 1.2 mg/kg per day, maximum 4.6 mg/kg per

day), and maximum doses of 8.6 mg/kg in paediatric patients and 8 mg/kg (median 50.0 mg per

day, maximum 896 mg per day) in adult patients, have been administered in clinical trials with

no reported dose-limiting toxicity. A newborn patient received a high initial dose of

7.8 mg/kg/day in a clinical trial, which following its detection after 7 days was decreased to

2.0 mg/kg/day. No ill effects associated with this high dose were noted.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic Properties

Micafungin, the active ingredient of MYCAMINE, is a member of the echinocandin

lipopeptide family and inhibits non-competitively the synthesis of 1,3-β-D-glucan, an essential

component of fungal cell walls which is not present in mammalian cells.

Microbiology

Micafungin exhibits fungicidal activity against most

Candida

species and inhibits actively

growing hyphae of

Aspergillus

species.

In vitro activity

Susceptibility testing was performed with modifications according to the Clinical and

Laboratory Standards Institute (CLSI) methods M27-A2 (

Candida

species) and M38-A

Aspergillus

species).

Micafungin displayed inhibitory activity against clinically relevant

Candida

species. The

Minimum Inhibitory Concentration (MIC) rank order was:

C. albicans

(including azole

resistant strains) <

C. tropicalis

C. glabrata

<

C. krusei

<<

C. parapsilosis

C. guilliermondii.

Micafungin displayed inhibitory activity against clinically relevant

Aspergillus

species

(A.

fumigatus

A. niger

A. flavus, A. nidulans, A. terreus and A. versicolor).

Micafungin has virtually no activity against

Cryptococcus neoformans

Trichosporon

cutaneum

Trichosporon asahii

Fusarium solani

Pseudallescheria boydii

Absidia

corymbifera

Cunninghamella elegans, Rhizopus oryzae, or Rhizopus microsporus.

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