Iloperidone (Fanapt)

Trade Name : Fanapt

Vanda Pharmaceuticals Inc.

TABLET

Strength 1 mg/1

ILOPERIDONE Atypical Antipsychotic [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Iloperidone (Fanapt) which is also known as Fanapt and Manufactured by Vanda Pharmaceuticals Inc.. It is available in strength of 1 mg/1 per ml. Read more

Iloperidone (Fanapt) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Contraindications ()u00a0u00a0u00a0u00a0u00a0u00a0 1/2016

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analysis of seventeen placebo-controlled trials (modal duration 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. FANAPT is not approved for the treatment of patients with Dementia-Related Psychosisn- [see Warnings and Precautions ()].
See full prescribing information for complete boxed warning.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. FANAPT is not approved for use in patients with dementia-related psychosis. ()

FANAPTu00a0tablets are indicated for the treatment of adults with schizophrenia. Efficacy was established in two short-term (4- and 6-week) placebo-and active-controlled studies of adult patients with schizophrenia .
When deciding among the alternative treatments available for this condition, the prescriber should consider the finding that FANAPTis associated with prolongation of the QTc interval .u00a0Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia which can result in sudden death.u00a0In many cases this would lead to the conclusion that other drugs should be tried first.u00a0Whether FANAPTu00a0will cause torsade de pointes or increase the rate of sudden death is not yet known.
Patients must be titrated to an effective dose of FANAPT.Thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared to some other antipsychotic drugs that do not require a similar titration.u00a0Prescribers should be mindful of this delay when selecting an antipsychotic drug for the treatment of schizophrenia .
The effectiveness of FANAPTu00a0in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials.u00a0Therefore, the physician who elects to use FANAPTu00a0for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient .
FANAPT is anu00a0atypical antipsychotic agent indicated for the treatment of schizophreniau00a0in adults. () Efficacy was established in two short-term (4- and 6-week) placebo- and active-controlled studies of adult patients with schizophrenia. () In choosing among treatments, prescribers should consider the ability of FANAPT to prolong the QT interval and theu00a0use of other drugs first.u00a0Prescribers should also consider the need to titrate FANAPT slowly to avoid orthostatic hypotension, which may lead to delayed effectiveness compared to some other drugs that do not require similar titration.u00a0

The recommended target dosage of FANAPT tablets is 12 to 24 mg/day administered twice daily. This target dosage range is achieved by daily dosage adjustments, alerting patients to symptoms of orthostatic hypotension, startingu00a0at a dose of 1 mg twice daily, then moving to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12u00a0mg twice daily on Days 2, 3, 4, 5, 6, and 7 respectively, to reach the 12 mg/day to 24 mg/day dose range.u00a0FANAPT can be administered without regard to meals. ()

FANAPT tablets are available in the following strengths: 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg.u00a0The tablets are white, round, flat, beveled-edged and identified with a logo u201cu201d debossed on one side and tablet strength u201c1u201d, u201c2u201d, u201c4u201d, u201c6u201d, u201c8u201d, u201c10u201d, or u201c12u201d debossed on the other side.
1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets. ()

FANAPT is contraindicated in individuals with a known hypersensitivity reaction tou00a0the product.u00a0Anaphylaxis, angioedema, and other hypersensitivity reactions have been reported [see Adverse Reactions ()].n
Known hypersensitivity to FANAPT or to any components in the formulation. (, )u00a0

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Elderly patients with dementia-related psychosis
QT prolongation:
Neuroleptic Malignant Syndrome:
Tardive dyskinesia:
Metabolic Changes:
Seizures:
Orthostatic hypotension:
Leukopenia, Neutropenia, and Agranulocytosis
Suicide:
Priapism:
Potential for cognitive and motor impairment:
See Full Prescribing Information for additional n

Commonly observed adverse reactionsu00a0(incidence u22655% and 2-fold greater than placebo) were: dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and weight increased. ()
To report SUSPECTED ADVERSE REACTIONS, contact Vanda Pharmaceuticals Inc. at 1-844-GO-VANDA (1-844-468-2632) or FDA at 1-800-FDA-1088 or .

Given the primary CNS effects of FANAPT, caution should be used when it is taken in combination with other centrally acting drugs and alcohol. Due to its - alpha1-adrenergic receptor antagonism, FANAPT has the potential to enhance the effect of certain antihypertensive agents.

The dose of FANAPT should be reduced in patients co-administered a strong CYP2D6 or CYP3A4 inhibitor. (, )

No data

Pregnancy: No human or animal data.u00a0Use only if clearly needed. ()n
Nursing Mothers: Should not breastfeed. ()n
Pediatric Use: Safety and effectiveness not established in children and adolescents. ()n
Hepatic Impairment:. FANAPT is not recommended for patients with severe hepatic impairment. (, )n
The dose of FANAPT should be reduced in patients who are poor metabolizers of CYP2D6. (, )

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FANAPT is a psychotropic agent belonging to the chemical class of piperidinyl-benzisoxazole derivatives.u00a0Its chemical name is 4u2019-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3u2019-methoxyacetophenone.u00a0Its molecular formula is CHFNO and its molecular weight is 426.48.u00a0The structural formula is:
Iloperidone is a white to off-white finely crystalline powder.u00a0It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile.
FANAPT tablets are intended for oral administration only.u00a0Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone.u00a0Inactive ingredients are: lactose monohydrate, microcrystalline cellulose, hydroxypropylmethylcellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and purified water (removed during processing). The tablets are white, round, flat, beveled-edged and identified with a logo u201cu201d debossed on one side and tablet strength u201c1u201d, u201c2u201d, u201c4u201d, u201c6u201d, u201c8u201d, u201c10u201d, or u201c12u201d debossed on the other side.

No data

Carcinogenesis:
The carcinogenic potential of the iloperidone metabolite P95, which is a major circulating metabolite of iloperidone in humans but is not present at significant amounts in mice or rats, was assessed in a lifetime carcinogenicity study in Wistar rats at oral doses of 25, 75 and 200 mg/kg/day in males and 50, 150, and 250 (reduced from 400) mg/kg/day in females.
Drug-related neoplastic changes occurred in males, in the pituitary gland (pars distalis adenoma) at all doses and in the pancreas (islet cell adenoma) at the high dose. Plasma levels of P95 (AUC) in males at the tested doses (25, 75, and 200 mg/kg/day) were approximately 0.4, 3, and 23 times, respectively, the human exposure to P95 at the MRHD of iloperidone.
An increase in mammary, pituitary and endocrine pancreas neoplasms has been found in rodents after chronic administration of other antipsychotic drugs and is considered to be mediated by prolonged dopamine D2 antagonism and hyperprolactinemia. Increases in serum prolactin were seen in mice and rats treated with iloperidone. The relevance of these tumor findings in rodents in terms of human risk is unknown.
Mutagenesis:
in vivo
in vitro
The iloperidone metabolite P95 was negative in the Ames test, the V79 chromosome aberration test, and an mouse bone marrow micronucleus test.
Impairment of Fertility:

The efficacy of FANAPT in the treatment of schizophrenia was supported byu00a02 placebo- and active-controlled short-term (4- and 6-week) trials.u00a0Both trials enrolled patients who met the DSM-III/IV criteria for schizophrenia.u00a0
Two instruments were used for assessing psychiatric signs and symptoms in these studies.u00a0The Positive and Negative Syndrome Scale (PANSS) and Brief Psychiatric Rating Scale (BPRS) are both multi-item inventories of general psychopathology usually used to evaluate the effects of drug treatment in schizophrenia.u00a0
A 6-week, placebo-controlled trial (n=706) involved 2 flexible dose ranges of FANAPT (12-16 mg/day or 20-24 mg/day) compared to placebo and an active control (risperidone). For the 12-16 mg/day group, the titration schedule of FANAPT was 1 mg twice daily on Days 1 and 2, 2 mg twice daily on Days 3 and 4, 4 mg twice daily on Days 5 and 6, and 6 mg twice daily on Day 7. For the 20-24 mg/day group, the titration schedule of FANAPT was 1 mg twice daily on Day 1, 2 mg twice daily on Day 2, 4 mg twice daily on Day 3, 6 mg twice daily on Days 4 and 5, 8 mg twice daily on Day 6, and 10 mg twice daily on Day 7. The primary endpoint was change from baseline on the BPRS total score at the end of treatment (Day 42). Both the 12-16 mg/day and the 20-24 mg/day dose ranges of FANAPT were superior to placebo on the BPRS total score. The active control antipsychotic drug appeared to be superior to FANAPT in this trial within the first 2 weeks, a finding that may in part be explained by the more rapid titration that was possible for that drug. In patients in this study who remained on treatment for at least 2 weeks, iloperidone appeared to have had comparable efficacy to the active control.
A 4-week, placebo-controlled trial (n=604) involved one fixed dose of FANAPT (24 mg/day) compared to placebo and an active control (ziprasidone). The titration schedule for this study was similar to that for the 6-week study. This study involved titration of FANAPT starting at 1 mg twice daily on Day 1 and increasing to 2, 4, 6, 8, 10 and 12 mg twice daily on Days 2, 3, 4, 5, 6, and 7. The primary endpoint was change from baseline on the PANSS total score at the end of treatment (Day 28). The 24 mg/day FANAPT dose was superior to placebo in the PANSS total score. FANAPT appeared to have similar efficacy to the active control drug which also needed a slow titration to the target dose.

FANAPT tablets are white, round and identified with a logo u201cu201d debossed on one side and tablet strength u201c1u201d, u201c2u201d, u201c4u201d, u201c6u201d, u201c8u201d, u201c10u201d, or u201c12u201d debossed on the other side. Tablets are supplied in the following strengths and package configurations:
Storage
Store FANAPT tablets at controlled room temperature, 25u00b0C (77u00b0F); excursions permitted to 15u00b0to 30 u00b0C (59u00b0 to 86u00b0F) [See USP Controlled Room Temperature]. Protect FANAPT tablets from exposure to light and moisture.

Physicians are advised to discuss the following issues with patients for whom they prescribe FANAPT:

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Iloperidone (Fanapt)

Trade Name : Fanapt

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Iloperidone (Fanapt)

Trade Name : Fanapt

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

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