Nolvadex online in Australia

What is NOLVADEX used for?

Treatment of breast carcinoma:

Whether in adjuvant treatment (preventive treatment of recurrences),

· Advanced forms with local and / or metastatic progression.

The effectiveness of this therapy is greater in women whose tumor contains estradiol and / or progesterone receptors.

Conditions for which this medicine may be prescribed

• Breast carcinoma

Method of administration and dosage of the drug NOLVADEX

Dose

In the indication of adjuvant treatment, the recommended dose is 20 mg per day, in one or two doses. Currently it is recommended to treat 5 years.

In the treatment of advanced forms, daily doses of between 20 and 40 mg are used, at the rate of one or two doses per day.

Pediatric population

The safety and efficacy of Nolvadex have not been established in children under the age of 18 years. Currently available data are described in the Pharmacodynamic Properties and Pharmacokinetic Properties sections, but no dosage recommendation can be given.

Possible side effects of the drug NOLVADEX

• Pseudohyperplastic atrophy of the endometrium
• Endometrial enlargement
• Endometrial polyp
• Endometrial cancer
• Malignant mixed Mullerian tumor of the endometrium
• Ischemic stroke
• Thromboembolic accident
• Deep thrombosis
• Microvascular flap complication during breast reconstruction
• Pulmonary embolism
• Visual disturbances
• Waterfall
• Corneal modification
• Retinopathy
• Optic neuropathy
• Blindness
• Paresthesia
• Dysesthesia
• Dysgeusia
• Peripheral sensory neuropathy
• Hot flushes
• Vulvar itching
• Sickness
• Leucorrhoea
• Acne
• Hives
• Polymorphic erythema
• Blistering pemphigus
• Stevens-Johnson syndrome
• Cutaneous vasculitis
• Allergic reaction
• Angioedema
• Alopecia
• Headache
• Worsening of cancer pain.
• Increased volume of the breast tumor.
• Hypercalcemia
• Leukopenia
• Anemia
• Thrombocytopenia
• Neutropenia
• Agranulocytosis
• Modification of liver enzymes.
• Hepatic steatosis
• Hepatic cholestasis
• Hepatitis
• Liver necrosis
• Cirrhosis
• Hepatocellular failure
• Pain in the breast tumor
• Water retention
• Hypertriglyceridaemia
• Pancreatitis
• Interstitial lung disease
• Arthralgia
• Lower limb cramp
• Myalgia
• Increased volume of ovarian cysts.
• Vaginal polyp
• Cutaneous lupus erythematosus
• Delayed cutaneous porphyria
• Tired
• Reactivation of the reaction to radiation.
• Amenorrhea
• Cycle irregularity
• High estradiol levels
• Ovarian cyst
• Metromethorrhagia
• Bone metastasis
• Uterine fibroma
• Hypersensitivity reaction
• Feeling dizzy
• Diarrhea
• Constipation
• Acute hepatitis
• Endometrial thickening
• Endometrial hyperplasia
• Endometriosis
• Vomiting
• Acute pancreatitis

Show more In all treated patients, you can see:

An increase in the frequency of endometrial abnormalities (pseudo-hyperplastic atrophies, hypertrophies, polyps, cancers) that require a prompt and thorough examination of any patient reporting bleeding (see Warnings and Precautions for Use section).

Rare cases of endometrial cancer and rare cases of uterine sarcoma (mainly malignant mixed Mullerian tumors) have been reported.

· Ischemic stroke and frequent thromboembolic events, including deep thrombosis, microvascular complications in the reconstruction flap in case of delayed reconstructive microsurgery (see: 'Warnings and precautions for use'. Special warnings and precautions for 'use') and pulmonary embolism. Thromboembolism increases when combined with cytotoxic agents.

Visual disorders including frequent cataracts, rare corneal changes, and / or frequent retinopathies, and for which ophthalmic monitoring is recommended.

· There have been reports of neuropathy and optic neuritis in patients receiving tamoxifen that can be complicated by unilateral or bilateral blindness.

Frequently: paresthesias, dysesthesias, dysgeusias and sensitive peripheral neuropathies.

Hot flushes and vulvar itching related to the antiestrogen effect.

· Rare phenomena of nausea that cause fractionation of therapy.

· Leucorrhea minor.

Skin manifestations: skin rashes, urticaria. Rare cases of severe skin manifestations have been described, such as erythema multiforme, bullous pemphigus, Stevens-Johnson syndrome, and cutaneous vasculitis.

· Frequent allergic reactions, including angioedema.

Alopecia

Headache

At the start of treatment, transient worsening of cancer symptoms (pain and / or increase in apparent tumor volume) is possible but rare.

· At the beginning of treatment, infrequently, patients with bone metastases have developed hypercalcemia.

Leukopenia sometimes associated with anemia and / or thrombocytopenia, exceptionally severe neutropenia; Cases of agranulocytosis have been rarely reported.

Changes in liver enzymes and more serious liver abnormalities, some of them fatal, such as steatosis, cholestasis, hepatitis, liver necrosis, cirrhosis, and hepatocellular failure.

· Rarely pain in the tumor and very rarely water retention.

Frequent cases of hypertriglyceridaemia or pancreatitis have been reported (see section 4.4).

· Interstitial lung disease has been reported infrequently.

· Frequent cases of arthralgia have been reported.

· Lower limb cramps and myalgia have been frequently reported.

Rarely, an increase in the volume of ovarian cysts.

Vaginal polyps have rarely been observed.

Very rarely, cases of cutaneous lupus erythematosus have been observed.

Very rare cases of late cutaneous porphyria have been observed.

· Fatigue has been reported very frequently.

· A resurgence of radiation reactions has been observed very rarely in patients taking Nolvadex.

In premenopausal women, some side effects are more specifically reported:

Amenorrhea or irregularities in the cycle.

Possibly a significant increase in circulating estradiol levels, associated with ovarian cysts and / or menometrorrhagia (see section 4.4).

The unwanted effects listed below are classified by frequency and by System Organ Class (SOC). The frequencies of occurrence of side effects are defined as follows:

Very common (≥1 / 10); common (≥1 / 100 to at least 1/10); uncommon (≥1 / 1,000 to at least 1/100); rare (≥1 / 10,000 to at least 1/1000); very rare (less than 1 / 10,000), frequency not known (cannot be estimated from the available data).

Unless otherwise indicated, frequencies have been calculated from the number of adverse events reported in a large phase III study, conducted in 9,366 postmenopausal patients with operable breast cancer treated for 5 years and, unless indicated Otherwise, the frequency within the comparative treatment groups or the existence, according to the researcher, of a causal link with the study drug were not taken into account.

a This side effect was not reported in the tamoxifen arm (n = 3094) in the previous study, but was reported in other trials or other sources. Frequency was calculated using the upper limit of the 95% confidence interval for the point estimate (based on 3 / X, where X represents the total sample size, for example 3094). It is calculated as 3/3094 which corresponds to the "rare" frequency category.

b This event has not been observed in other important clinical studies. Frequency was calculated using the 95% upper confidence interval for point estimation (based on 3 / X, where X represents the total sample size of 13,357 patients in major clinical studies). Calculated as corresponding 3/13 357 to the "very rare" frequency category.

Contraindications: when not to use this medicine?

• Hypersensitivity to tamoxifen
• Pregnancy
• Lack of effective non-hormonal contraception
• Breastfeeding
• Child under 6
• Child from 6 to 18 years old.
• Galactose intolerance
• Glucose malabsorption syndrome
• Galactose malabsorption syndrome
• Lactase deficiency

Show more · Pregnancy.

· Breastfeeding.

Hypersensitivity to the active substance or to any of the excipients included in the Composition section.

Presentation of this medicine

30, 90 or 100 tablets in blister (aluminum / polyamide).

Not all presentations can be marketed.

Appearance and shape

Compressed film.

NOLVADEX: its other forms

• NOLVADEX 20 mg, coated tablet, box of 100 film-coated tablets.
• NOLVADEX 20 mg, coated tablet, box of 30
• NOLVADEX 10 mg film-coated tablet, box of 100

Composition of the drug NOLVADEX

* per unit dose Active ingredients: Tamoxifen excipients with known effects? : Lactose monohydrate Other excipients: Corn starch, Gelatin, Carmellose sodium, Magnesium stearate, Hypromellose, Macrogol 300, Titanium dioxide Effects on ability to drive and use machines

The attention of drivers or users of machinery should be drawn to the risks of visual disturbances and fatigue associated with the use of this medicine.

Warnings and precautions for use

• Gynecological monitoring
• Thromboembolic accident risk.
• Hypertriglyceridaemia
• Endometrial abnormality
• Abnormal vaginal bleeding
• Premenopausal woman

Warnings

The risk of developing endometrial cancer and uterine sarcoma (mainly mixed Muller's neoplasms) is increased in the tamoxifen-treated population, compared to an untreated control population, and warrants careful gynecological monitoring. (See Warnings and Precautions for Use Precautions for Use).

Primary prevention of breast cancer with tamoxifen (i.e. administration of the product to unaffected women) is not warranted in the absence of proven efficacy to date.

Due to the presence of lactose, this drug is contraindicated in cases of congenital galactosemia, glucose-galactose malabsorption syndrome, or lactase deficiency.

In the literature, people who are slow metabolizers of CYP2D6 have been shown to have a lower plasma level of endoxifene, one of the most important active metabolites of tamoxifen (see Pharmacokinetic properties section).

Concomitant treatments that inhibit CYP2D6 can lead to reduced concentrations of the active metabolite, endoxifene. Therefore, strong CYP2D6 inhibitors (eg paroxetine, fluoxetine, quinidine, cinacalcet or bupropion) should be avoided whenever possible during treatment with tamoxifen (see sections Interactions with other medicinal products and other forms of interaction and pharmacokinetic properties ).

Employment precautions

In all treated patients:

· Close monitoring is recommended in patients at risk of thromboembolic events.

Due to the risk of hypertriglyceridaemia and pancreatitis, careful monitoring is recommended in patients with hypertriglyceridaemia.

The determination of the levels of estradiol receptor and / or progesterone in the tumor or its metastases, before starting treatment, has a prognostic value (see section Therapeutic indications).

· A complete gynecological examination is necessary, in search of a pre-existing endometrial anomaly, before the start of treatment, then associated with at least one annual monitoring.

In addition, the patient will be warned about the need for a quick consultation in case of abnormal vaginal bleeding: comprehensive examinations should be performed. In fact, an increase in the frequency of endometrial abnormalities (hyperplasias, polyps, cancers; see sections Warnings and precautions for use and adverse effects) has been observed, probably related to the estrogenic activity of tamoxifen in the endometrium.

· In case of delayed microsurgical breast reconstruction, Nolvadex may increase the risk of complications at the microvascular level of the flap.

Monitor liver function during long-term treatment (over two years) (see Preclinical Safety Data section).

In premenopausal women:

Tamoxifen, as an antiestrogen, can cause large increases in plasma estradiol concentrations (1,000 to 2,000 picograms per milliliter).

The premenopausal woman is thus exposed:

Maintain fertility, at risk of pregnancy, theoretically contraindicated in case of breast cancer.

On the appearance of functional ovarian cysts, menometrorrhagia.

The appearance of these side effects may require resting the ovary.

Pediatric population

The use of Nolvadex is not recommended in children and adolescents, since tolerance and efficacy have not been established in this group of patients.

Mechanism of action: how does it work?

Pharmacotherapeutic group: ANTISTROGEN, ATC code: L02BA01 (L: antineoplastic and immunomodulatory).

Mechanism of action

Anti-estrogen by competitive inhibition of the binding of estradiol with its receptors.

In addition, tamoxifen has an estrogenic effect on various tissues, such as the endometrium and bones (decreased postmenopausal bone loss) and blood lipids (decreased LDL cholesterol).

Clinical efficacy and safety

In patients whose tumor has or is unknown to estrogen receptor positive, tamoxifen treatment has shown a significant reduction in disease recurrence and better 10-year survival.

The effect is significantly greater for a 5 year treatment compared to 1 or 2 year treatments. This efficacy appears to be independent of age, menopausal status, tamoxifen dose, and any additional chemotherapy.

The efficacy and safety of the long-term effects of tamoxifen have not been studied.

The status of the CYP2D6 polymorphism may be associated with variability in the clinical response to tamoxifen. The slow state of the metabolizer may be associated with a reduced response. The consequences of these findings for the treatment of slow CYP2D6 metabolizers have not been fully elucidated (see sections 4.4 and 4.4).

CYP2D6 genotype

Available clinical data suggests that patients who are homozygous for non-functional CYP2D6 alleles may have a decreased effect of tamoxifen in the treatment of breast cancer. Available studies have been carried out mainly in postmenopausal women (see sections 4.4 and 5.1).

Pediatric population

An uncontrolled trial was conducted in a group of 28 girls aged 2 to 10 years with McCune Albright syndrome (SAM) who received 20 mg of tamoxifen daily for 12 months. A reduction in the frequency of vaginal bleeding episodes has been observed, as well as a decrease in the progression of maturation and bone growth. Two patients experienced treatment-related side effects (increased transaminases and alopecia).

Interactions: do not take this medicine with ..

Associations subject to precautions for use.

Antivitamins K

Increased thrombotic and hemorrhagic risk during tumor diseases. Also, possible interaction between antivitamins K and chemotherapy.

More frequent INR monitoring.

· Cytotoxic agents

Risk of increased thromboembolic events.

A pharmacokinetic interaction with CYP2D6 inhibitors, showing a 65-75% reduction in plasma levels of endoxifene, one of the most active forms of the drug, has been reported in the literature. A decrease in the effectiveness of tamoxifen has been reported in some studies with the concomitant use of certain SSRI antidepressants (a selective serotonin reuptake inhibitor) (eg paroxetine). Since a reduction in the effect of tamoxifen cannot be excluded, co-administration with potent CYP2D6 inhibitors (eg paroxetine, fluoxetine, quinidine, cinacalcet, terbinafine or bupropion) should be avoided whenever possible (see care and precautions for use and pharmacokinetic properties).

Incompatibilities

Aimlessly.

How to react in case of overdose?

Cases of QT interval prolongation have been observed after administration of tamoxifen at doses several times higher than the recommended dose, in clinical studies.

Neurological manifestations (tremors, hyperreflexia, dysmetry, dizziness, gait disturbances, seizures) have been observed in patients receiving high doses of tamoxifen in clinical studies.

NOLVADEX: pregnancy, lactation and fertility

Pregnancy

Due to the malformation effect of tamoxifen, found in animal experiments, the possibility of pregnancy should be eliminated before any prescription and up to 2 months after stopping treatment.

Provide an effective method of contraception, without using an estrogen derivative.

Breastfeeding

Breast cancer contraindicates breastfeeding.