LURASIDONE HCL*
Manufacturer DetailsSUNOVION PHARMACEUTICALS INC.
Compositions:
Lurasidone Hcl-mg,
Lurasidone Hcl-mg,
| Strength | Rate | Packing Style |
|---|---|---|
| mg | 0.00 | unit |
List of Related Indications:
- Treatment of schizophrenia in adults
List Of Drugs:
- Lurasidone Hcl- Lurasidone HCl-Anti-convulsant (Oct 2010)
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Avoid the use of Exjade with aluminum-containing antacid preparations.
Indication:
Proprietary Name- Lurasidone Hydrochloride
Established Name - Lurasidone hydrochloride
Applicant- Sunovion pharmaceuticals Inc.
Indication-
Indicated for the treatment of schizophrenia in adults
Approved by FDA on 28-10-2010 (Ref- FDA approved List- 2010)
LIST OF NEW DRUG APPROVED FROM 01-01-2016 To TILL DATE
BY NEW DRUG DIVISION - DRUG CONTROLLER GENERAL- INDIA
Sr.No Name of Drug Indication Date of Issue
12. Lurasidone hydrochloride Bulk 18-07-2016
Lurasidone Hydrochloride
Tablets 40mg/80mg
For the treatment of Patients with Schizophrenia
Approved by DCG INDIA (Ref- DCGI approved List- 18-07-2016 To Till Date
Adverse Reaction:
In patients with transfusional iron overload, the most frequently occurring (>5%)
adverse reactions are diarrhea, vomiting, nausea, abdominal pain, skin rashes,
and increases in serum creatinine.
In Exjade-treated patients with NTDT syndromes, the most frequently occurring
(>5%) adverse reactions are diarrhea, rash and nausea.
Contra-Indications:
CONTRAINDICATIONS
Serum creatinine greater than 2 times the age-appropriate upper limit of
normal or creatinine clearance less than 40 mL/min.
- Patients with poor performance status.
- Patients with high-risk myelodysplastic syndromes (MDS).
-Patients with advanced malignancies.
-Patients with platelet counts <50 x 109/L.
WARNINGS AND PRECAUTIONS
Renal toxicity: Measure serum creatinine and creatinine clearance in duplicate
before starting therapy. Monitor renal function during Exjade therapy and
reduce dose or interrupt therapy for toxicity.
Hepatic toxicity: Monitor hepatic function. Reduce dose or interrupt therapy for toxicity.
Fatal and nonfatal gastrointestinal bleeding, ulceration, and irritation:
Risk may be greater in patients who are taking Exjade in combination
with drugs that have known ulcerogenic or hemorrhagic potential.
Bone marrow suppression: Neutropenia, agranulocytosis, worsening anemia,
and thrombocytopenia, including fatal events; monitor blood counts during
Exjade therapy. Interrupt therapy for toxicity.
Elderly: Monitor closely for toxicity due to the greater frequency of decreased
hepatic, renal, and/or cardiac function.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
Exjade is an iron chelator indicated for the treatment of chronic iron overload
due to blood transfusions in patients 2 years of age and older.
This indication is based on reduction in serum ferritin and liver iron
concentration (LIC). An improvement in survival or disease-related
symptoms has not been established.
Exjade is indicated for the treatment of chronic iron overload in patients
10 years of age and older with non-transfusion-dependent thalassemia
(NTDT) syndromes and with a liver iron (Fe) concentration (LIC)
of at least 5 mg Fe per gram of dry weight and a serum ferritin greater
than 300 mcg/L.
This indication is based on achievement of an LIC less than 5 mg Fe/g dw.
An improvement in survival or disease-related symptoms has not been established.
In patients with transfusional iron overload, the recommended initial daily
dose is 20 mg per kg body weight once daily, as oral suspension.
Calculate dose to the nearest whole tablet.
In patients with NTDT syndromes, the recommended initial daily dose
is 10 mg per kg body weight once daily, as oral suspension.
Calculate dose to the nearest whole tablet.
Monitor serum ferritin monthly and adjust dose accordingly.
Monitor LIC every 6 months and adjust dose accordingly.
Do not chew or swallow tablets whole.
Take on an empty stomach at least 30 minutes before food.
Disperse tablets by stirring in an appropriate amount of water,
orange juice, or apple juice.
Reduce the starting dose in patients with moderate (Child-Pugh B)
hepatic impairment by 50%.
Avoid the use of Exjade in patients with severe (Child-Pugh C)
hepatic impairment.
Reduce the starting dose by 50% in patients with renal impairment
(ClCr 40– 60 mL/min).
DOSAGE FORMS AND STRENGTHS
Tablets for oral suspension: 125 mg, 250 mg, 500 mg.
Pharmacology/ Pharmacokinetics:
1 Mechanism of Action
Exjade (deferasirox) is an orally active chelator that is selective for iron
(as Fe3+). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio.
Although deferasirox has very low affinity for zinc and copper there are variable
decreases in the serum concentration of these trace metals after the
administration of deferasirox. The clinical significance of these decreases is uncertain.
2 Pharmacodynamics
Pharmacodynamic effects tested in an iron balance metabolic study showed
that deferasirox (10, 20, and 40 mg per kg per day) was able to induce a
mean net iron excretion (0.119, 0.329, and 0.445 mg Fe/kg body weight per day
, respectively) within the clinically relevant range (0.1-0.5 mg per kg per day).
Iron excretion was predominantly fecal.
3 Pharmacokinetics
Absorption
Exjade is absorbed following oral administration with median times to maximum
plasma concentration (tmax) of about 1.5-4 hours.
The Cmax and AUC of deferasirox increase approximately linearly with dose
after both single administration and under steady-state conditions.
Exposure to deferasirox increased by an accumulation factor of 1.3-2.3
after multiple doses.
The absolute bioavailability (AUC) of deferasirox tablets for oral suspension
is 70% compared to an intravenous dose.
The bioavailability (AUC) of deferasirox was variably increased when taken with a meal.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1 Pregnancy
Pregnancy Category C
There are no adequate and well-controlled studies with Exjade in pregnant women.
Administration of deferasirox to animals during pregnancy and lactation resulted
in decreased offspring viability and an increase in renal anomalies in male
offspring at exposures that were less than the recommended human exposure.
Exjade should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus
2. Nursing Mothers
It is not known whether Exjade is excreted in human milk. Deferasirox and
its metabolites were excreted in rat milk. Because many drugs are excreted
in human milk and because of the potential for serious adverse reactions
in nursing infants from deferasirox and its metabolites, a decision should be
made whether to discontinue nursing or to discontinue the drug, taking into
account the importance of the drug to the mother
3. Pediatric Use
Of the 700 patients with transfusional iron overload who received Exjade during
clinical studies, 292 were pediatric patients 2-<16 years of age with various
congenital and acquired anemias, including 52 patients age 2-<6 years,
121 patients age 6-<12 years and 119 patients age 12-<16 years.
Seventy percent of these patients had beta-thalassemia
. Children between the ages of 2-<6 years have a systemic exposure to Exjade
approximately 50% of that of adults [see Clinical Pharmacology (12.3)].
However, the safety and efficacy of Exjade in pediatric patients was similar
to that of adult patients, and younger pediatric patients responded similarly
to older pediatric patients. The recommended starting dose and dosing
modification are the same for children and adults
4. Geriatric Use
Four hundred thirty-one (431) patients .65 years of age were studied in clinical trials
of Exjade in the transfusional iron overload setting. The majority of these
patients had myelodysplastic syndrome (MDS) (n=393). In these trials,
elderly patients experienced a higher frequency of adverse reactions
than younger patients. Monitor elderly patients for early signs or symptoms
of adverse reactions that may require a
dose adjustment.
Elderly patients are at increased risk for toxicity due to the
greater frequency of decreased hepatic, renal, or cardiac function,
and of concomitant disease or other drug therapy. Dose selection f
or an elderly patient should be cautious, usually starting at the low end of the dosing range
