Everolimus (Zortress)

Trade Name : Zortress

Novartis Pharmaceuticals Corporation

TABLET

Strength 0.5 mg/1

EVEROLIMUS Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Decreased Immunologic Activity [PE]

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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 Everolimus (Zortress) which is also known as Zortress and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 0.5 mg/1 per ml. Read more

Everolimus (Zortress) 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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Malignancies and Serious Infections
Kidney Graft Thrombosis
Nephrotoxicity
Mortality in Heart Transplantation

Only physicians experienced in immunosuppressive therapy and management of transplant patients should usen- u00a0n- Zortressu00a0n- )
Increased susceptibility to infection and the possible development of malignancies may result from immunosuppressionn- u00a0n- (n- , n- )
5.2n- 5.3
Increased incidence of kidney graft thrombosisu00a0(n- )
Reduced doses of cyclosporine are required for use in combination with n- Zortress n- in order to n- reduce n- nephrotoxicityn- u00a0n- (n- , n- , n- , n- , n- )
2.4n- 2.5n- 5.6n- 12.7n- 12.8
Increased mortality in a heart transplant clinical trial. Use in heart transplantation is not recommendedn- u00a0n- (n- )

u2022 Zortress is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients:u00a0
u2022 at low-moderate immunologic risk.u00a0Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids. ()
u2022 Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids. (, )n
Limitations of Use
Safety and efficacy have not been established in the following:
u2022 Kidney transplant patients at high immunologic risk ()
u2022 Recipients of transplanted organs other than kidney or liver (, )u00a0
u2022 Pediatric patients (less than 18 years) ()u00a0

Patients receiving Zortress may require dose adjustments based on everolimus blood concentrations achieved, tolerability, individual response, change in concomitant medications and the clinical situation. Optimally, dose adjustments of Zortress should be based on trough concentrations obtained 4 or 5 days after a previous dosing change. Dose adjustment is required if the trough concentration is below 3 ng/mL. The total daily dose of Zortress should be doubled using the available tablet strengths (0.25 mg, 0.5 mg, 0.75 mg or 1 mg). Dose adjustment is also required if the trough concentration is greater than 8 ng/mL on 2 consecutive measures; the dose of Zortress should be decreased by 0.25 mg twice dailyu00a0n n n n n n n n
u2022 starting oral dose of 0.75 mg twice dailyu00a0as soon as possible after transplantationu00a0()
u2022 starting oral dose of 1 mg twice daily starting 30 days after transplantation ()
u2022 Adjust maintenance doseu00a0to achieve trough concentrations within the 3-8 ng/mL target range using LC/MS/MS assay method. (, ,u00a0)
u2022 Administer consistently withu00a0or without food at theu00a0same time as cyclosporine or tacrolimus (, )
u2022 Reduce initial daily dose by one-thirdu00a0()
u2022 Reduce initial daily dose by one-half (, )

Zortress is available as 0.25 mg, 0.5 mg, 0.75 mg and 1 mg tablets.
Zortress is available as 0.25 mg, 0.5 mg, 0.75 mg and 1 mg tablets ()

Zortressu00a0is contraindicated in patients with known hypersensitivity to everolimus, sirolimus, or to components of the drug product.u00a0
u2022u00a0Hypersensitivity to everolimus, sirolimus, or to components of the drug product ()

u2022 Monitor for symptoms and treat promptly ()
u2022 Monitor symptoms; treat promptly to minimize complications ()
u2022 Monitor for symptoms or radiologic changes; manage by dose reduction or discontinuation until symptoms resolve; consider use of corticosteroids ()
u2022 Monitor and consider anti-lipid therapy ()
u2022 u00a0Monitor urine protein ()u00a0
u2022 Consider reducing immunosuppression ()
u2022u00a0u00a0Monitor foru00a0hematological changes or symptoms ()
u2022u00a0 Monitor serum glucose ()
u2022 Azospermia or oligospermia may occur (, )
u2022 Avoid live vaccines ()
u2022 Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with Zortress and for 8 weeks after final dose (, , )

Most common adverse reactions were as follows:
To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or .

Kidney Transplantationu00a0(incidence greater than or equal to 20%):
Liver Transplantationu00a0(incidence greater than 10%):

Strong-moderate CYP3A4 inhibitors (e.g., cyclosporine, ketoconazole, erythromycin, verapamil) and CYP3A4 inducers (e.g., rifampin) may affect everolimus concentrations ().u00a0Consider Zortress dose adjustment ()

u2022 Based on animal data may cause maternal and fetal harm. ()
u2022 Breastfeeding not recommended.u00a0()
u2022 May impair fertilityu00a0(, , )
nttu00a0u00a0u00a0u00a0u00a0nt
nttu00a0u00a0u00a0u00a0u00a0nt

Reported experience with overdose in humans is very limited. There is a single case of an accidental ingestion of 1.5u00a0mg everolimus in a 2-year-old child where no adverse reactions were observed. Single doses up to 25u00a0mg have been administered to transplant patients with acceptable acute tolerability. Single doses up tou00a070u00a0mgu00a0(without cyclosporine) have been given with acceptable acute tolerability. General supportive measures shouldu00a0be followed in all cases of overdose. Everolimus is not considered dialyzable to any relevant degree (less than 10% of everolimus removed within 6 hours of hemodialysis). In animal studies, everolimus showed a low acute toxic potential. No lethality or severe toxicity was observed after single oral doses of 2000u00a0mg/kg (limit test) in either mice or rats.

Zortress (everolimus) is a macrolide immunosuppressant.u00a0
The chemical name of everolimus isu00a0(1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12u00a0-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.0] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone.
The molecular formula is CHNO and the molecular weight is 958.25 g/mol. The structural formula is:
Zortress is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg and 1 mg of everolimus together with butylated hydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone and lactose anhydrous as inactive ingredients.

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Zortress (everolimus) tablets are packed in child-resistant blisters.
Each strength is available in boxes of 60 tablets (6 blister strips of 10 tablets each).
Storage
Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].
Protect from light and moisture.

Administration
Inform patients that Zortress should be taken orally twice a day approximately 12 hours apart consistently either with or without food.
Inform patients to avoid grapefruit and grapefruit juice which increase blood drug concentrations of Zortressu00a0[n n n n n ].
Advise patients that Zortress should be used concurrently with reduced doses of cyclosporine and that any change in doses of these medicationsu00a0should be made under physician supervision. A change in the cyclosporine dose may also require a change in the dosage of Zortress.u00a0
Inform patients of the necessity of repeated laboratory tests according to physician recommendations while they are takingu00a0Zortress.
Development of Lymphomas and Other n- Malignancies
Inform patientsu00a0they are at risk of developing lymphomas and other malignancies, particularly of the skin, due to immunosuppression.u00a0Advise patients to limit exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and using a sunscreen with a high protection factor n n n n n n n
Increan- sn- ed Risk of Infectionn- u00a0
Inform patients they are at increased risk of developing a variety of infections, including opportunistic infections, due to immunosuppression. Advise patients to contact their physician if they develop any symptoms of infection n n n n n n n n n n
Kidney n- Graft Thrombosis
Inform patients that Zortress has been associated with an increased risk of kidney arterial and venous thrombosis, resulting in graft loss, usually within the first 30 days posttransplantationn n n n n n n n
Zortress n- and Calcineurin Inhibitor-Induced n- Nephrotoxicity
Advise patients of the risks of impaired kidney function with the combination of Zortress and cyclosporine as well as the need for routine blood concentration monitoring for both drugs. Advise patients of the importance of serum creatinine monitoringu00a0n n n n n n n n n n n
Angioedema
Inform patients of the risk of angioedema and that concomitant use of ACE inhibitors may increase this risk. Advise patients to seek prompt medical attention if symptoms occuru00a0n n n n n n n n n
Wound Healing Complications and Fluid Accumulation
Inform patients the use of Zortress has been associated with impaired or delayed wound healing, fluid accumulation and the need for careful observation of their incision site n n n n n n n n u00a0
Interstitial Lung Disease (ILD)/Non-Infectious Pneumonitis
Inform patients the use of Zortress may increase the risk of non-infectious pneumonitis. Advise patients to seek medical attention if they develop clinical symptoms consistent with pneumonia n n n n n n n
Hyperlipidemia
Inform patients the use of Zortress has been associated with increased serum cholesterol and triglycerides that may require treatment and the need for monitoring of blood lipid concentrations n n n n n n n n n
Proteinuria
Inform patients the use of Zortress has been associated with an increased risk of proteinurian n n n n n n n n
Pregnancy and Lactation
Advise women of childbearing age to avoid becoming pregnant throughout treatment and for 8 weeks after Zortress therapy has stopped. Zortress can cause fetal harm if taken during pregnancy. Advise a pregnant woman of the potential risk to a fetus. Also advise not to breastfeed while taking Zortress .
Male and Female Fertility
Inform male and female patients that Zortress may impair fertility .
Medications that Interfere with Zortress
Some medications can increase or decrease blood concentrations of Zortress. Advise patients to inform their physician if they are taking any of the following: antifungals, antibiotics, antivirals, anti-epileptic medicines including carbamazepine, phenytoin and barbiturates, herbal/dietary supplements (St. Johnu2019s Wort), and/or rifampinu00a0n n n n n n n n n n
New Onset Diabetes
Inform patients the use of Zortress may increase the risk ofu00a0diabetes mellitus and to contact their physician if they develop symptomsu00a0n n n n n n n n n n n
Immunizations
Inform patients that vaccinations may be less effective while they are being treated with Zortress. Advise patients live vaccines should be avoidedu00a0n n n n n n n n n n
Patient with Hereditary Disorders
Advise patients to inform their physicians that if they have hereditary disorders of galactose intolerance (Lapp-lactase deficiency or glucose-galactose malabsorption) not to take Zortress n n n n n n n n n
Distributed by:Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936
u00a9 Novartis
T2018-110

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PRINCIPAL DISPLAY PANEL
Package Label u2013 n- 0.25 mg

PRINCIPAL DISPLAY PANEL
Package Label u2013 n- 0.5 mg

PRINCIPAL DISPLAY PANEL
Package Label u2013 n- 0n- .75n- mg

PRINCIPAL DISPLAY PANEL
Package Label u2013 n- 1 mg

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Everolimus (Zortress)

Trade Name : Zortress

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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Everolimus (Zortress)

Trade Name : Zortress

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

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Canadian DIN

Swiss Drugs

NZ Drugs

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