Sigma-tau Pharmaceuticals, Inc.

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Sigma-tau Pharmaceuticals, Inc. Drugs

Depocyt

Depocyt

2.1 Preparation and Administration Precautions

DepoCyt is a cytotoxic anticancer drug and, as with other potentially toxic compounds, caution should be used in handling DepoCyt. The use of gloves is recommended. If DepoCyt suspension contacts the skin, wash immediately with soap and water. If it contacts mucous membranes, flush thoroughly with water.

2.2 Preparation and Administration

No further reconstitution or dilution is required. DepoCyt particles have a tendency to settle with time. Vials of DepoCyt should be allowed to warm to room temperature and gently agitated or inverted to re-suspend the particles immediately prior to withdrawal from the vial. Avoid aggressive agitation.

DepoCyt should be withdrawn from the vial immediately before administration. DepoCyt is a single dose vial and does not contain any preservative. DepoCyt should be used within 4 hours of withdrawal from the vial. Unused portions of each vial should be discarded properly [see How Supplied/ Storage and Handling (16)]. Do not save any unused portions for later administration. Do not mix DepoCyt with any other medications.

2.3 Dosing Precautions

In-line filters must not be used when administering DepoCyt. DepoCyt is administered directly into the cerebrospinal fluid (CSF) via an intraventricular reservoir or by direct injection into the lumbar sac. DepoCyt should be injected slowly over a period of 1-5 minutes. Following drug administration by lumbar puncture, the patient should be instructed to lie flat for 1 hour. Patients should be observed by the physician for immediate toxic reactions.

2.4 Dosing Regimen

For the treatment of lymphomatous meningitis, DepoCyt 50 mg (one vial of DepoCyt) is recommended to be given according to the following schedule:
Induction therapy DepoCyt, 50 mg, administered intrathecally (intraventricular or lumbar puncture) every 14 days for 2 doses (weeks 1 and 3). Consolidation therapy DepoCyt, 50 mg, administered intrathecally (intraventricular or lumbar puncture) every 14 days for 3 doses (weeks 5, 7 and 9) followed by 1 additional dose at week 13. Maintenance DepoCyt, 50 mg, administered intrathecally (intraventricular or lumbar puncture) every 28 days for 4 doses (weeks 17, 21, 25 and 29).
Patients should be started on dexamethasone 4 mg twice a day either by mouth or intravenously for 5 days beginning on the day of DepoCyt injection.

If drug related neurotoxicity develops, the dose should be reduced to 25 mg. If it persists, treatment with DepoCyt should be discontinued.
Diflunisal

Diflunisal

Instill one drop of CYSTARAN in each eye, every waking hour.

Do not touch dropper tip to any surface, as this may contaminate the solution.

Discard after 1 week of use.
Matulane

Matulane

The following doses are for administration of the drug as a single agent. When used in combination with other anticancer drugs, the Matulane dose should be appropriately reduced, eg, in the MOPP regimen, the Matulane dose is 100 mg/m2 daily for 14 days. All dosages are based on the patient's actual weight. However, the estimated lean body mass (dry weight) is used if the patient is obese or if there has been a spurious weight gain due to edema, ascites or other forms of abnormal fluid retention.

Adults: To minimize the nausea and vomiting experienced by a high percentage of patients beginning Matulane therapy, single or divided doses of 2 to 4 mg/kg/day for the first week are recommended. Daily dosage should then be maintained at 4 to 6 mg/kg/day until maximum response is obtained or until the white blood count falls below 4000/cmm or the platelets fall below 100,000/cmm. When maximum response is obtained, the dose may be maintained at 1 to 2 mg/kg/day. Upon evidence of hematologic or other toxicity (see PRECAUTIONS section), the drug should be discontinued until there has been satisfactory recovery. After toxic side effects have subsided, therapy may then be resumed at the discretion of the physician, based on clinical evaluation and appropriate laboratory studies, at a dosage of 1 to 2 mg/kg/day.

Pediatric Patients: Very close clinical monitoring is mandatory. Undue toxicity, evidenced by tremors, coma and convulsions, has occurred in a few cases. Dosage, therefore, should be individualized. The following dosage schedule is provided as a guideline only.

Fifty (50) mg per square meter of body surface per day is recommended for the first week. Dosage should then be maintained at 100 mg per square meter of body surface per day until maximum response is obtained or until leukopenia or thrombocytopenia occurs. When maximum response is attained, the dose may be maintained at 50 mg per square meter of body surface per day. Upon evidence of hematologic or other toxicity (see PRECAUTIONS section), the drug should be discontinued until there has been satisfactory recovery, based on clinical evaluation and appropriate laboratory tests. After toxic side effects have subsided, therapy may then be resumed.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-6 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
Carnitor Sf

Carnitor Sf

CARNITOR® (levocarnitine) Tablets.

Adults: The recommended oral dosage for adults is 990 mg two or three times a day using the 330 mg tablets, depending on clinical response.

Infants and children: The recommended oral dosage for infants and children is between 50 and 100 mg/kg/day in divided doses, with a maximum of 3 g/day. Dosage should begin at 50 mg/kg/day. The exact dosage will depend on clinical response.

Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations and overall clinical condition.

CARNITOR® (levocarnitine) Oral Solution and CARNITOR® SF (levocarnitine) Sugar-Free Oral Solution.

For oral use only. Not for parenteral use.

Adults: The recommended dosage of levocarnitine is 1 to 3 g/day for a 50 kg subject, which is equivalent to 10 to 30 mL/day of CARNITOR® (levocarnitine) Oral Solution or CARNITOR® SF (levocarnitine) Sugar-Free Oral Solution. Higher doses should be administered only with caution and only where clinical and biochemical considerations make it seem likely that higher doses will be of benefit. Dosage should start at 1 g/day, (10 mL/day), and be increased slowly while assessing tolerance and therapeutic response. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition.

Infants and children: The recommended dosage of levocarnitine is 50 to 100 mg/kg/day which is equivalent to 0.5 mL/kg/day CARNITOR® (levocarnitine) Oral Solution or CARNITOR® SF (levocarnitine) Sugar-Free Oral Solution. Higher doses should be administered only with caution and only where clinical and biochemical considerations make it seem likely that higher doses will be of benefit. Dosage should start at 50 mg/kg/day, and be increased slowly to a maximum of 3 g/day (30 mL/day) while assessing tolerance and therapeutic response. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition.

CARNITOR® (levocarnitine) Oral Solution or CARNITOR® SF (levocarnitine) Sugar-Free Oral Solution may be consumed alone or dissolved in drink or other liquid food. Doses should be spaced evenly throughout the day (every three or four hours) preferably during or following meals and should be consumed slowly in order to maximize tolerance.
Abelcet

Abelcet

The recommended daily dosage for adults and children is 5 mg/kg given as a single infusion. ABELCET® should be administered by intravenous infusion at a rate of 2.5 mg/kg/h. If the infusion time exceeds 2 hours, mix the contents by shaking the infusion bag every 2 hours.

Renal toxicity of ABELCET®, as measured by serum creatinine levels, has been shown to be dose dependent. Decisions about dose adjustments should be made only after taking into account the overall clinical condition of the patient.

Preparation of Admixture for Infusion: Shake the vial gently until there is no evidence of any yellow sediment at the bottom. Withdraw the appropriate dose of ABELCET® from the required number of vials into one or more sterile syringes using an 18-gauge needle. Remove the needle from each syringe filled with ABELCET® and replace with the 5-micron filter needle supplied with each vial. Each filter needle may be used to filter the contents of up to four 100 mg vials. Insert the filter needle of the syringe into an IV bag containing 5% Dextrose Injection USP, and empty the contents of the syringe into the bag. The final infusion concentration should be 1 mg/mL. For pediatric patients and patients with cardiovascular disease the drug may be diluted with 5% Dextrose Injection to a final infusion concentration of 2 mg/mL. Before infusion, shake the bag until the contents are thoroughly mixed. Do not use the admixture after dilution with 5% Dextrose Injection if there is any evidence of foreign matter. Vials are for single use. Unused material should be discarded. Aseptic technique must be strictly observed throughout handling of ABELCET®, since no bacteriostatic agent or preservative is present.

DO NOT DILUTE WITH SALINE SOLUTIONS OR MIX WITH OTHER DRUGS OR ELECTROLYTES as the compatibility of ABELCET® with these materials has not been established. An existing intravenous line should be flushed with 5% Dextrose Injection before infusion of ABELCET®, or a separate infusion line should be used. DO NOT USE AN IN-LINE FILTER.

The diluted ready-for-use admixture is stable for up to 48 hours at 2° to 8°C (36° to 46°F) and an additional 6 hours at room temperature.
Oncaspar

Oncaspar

2.1 Recommended Dose
The recommended dose of Oncaspar ® is 2,500 International Units/m 2 intramuscularly or intravenously. Oncaspar ® should be administered no more frequently than every 14 days.
2.2 Instructions for Administration
When Oncaspar ® is administered intramuscularly, the volume at a single injection site should be limited to 2 mL. If the volume to be administered is greater than 2 mL, multiple injection sites should be used. Oncaspar ® does not contain a preservative. Use only one dose per vial; discard unused product. When administered intravenously, Oncaspar ® should be given over a period of 1 to 2 hours in 100 mL of sodium chloride or dextrose injection 5%, through an infusion that is already running. After the solution is diluted for intravenous use, the solution should be used immediately. If immediate use is not possible, the diluted solution should be stored refrigerated at 2°C to 8°C (36°F to 46°F). Storage after dilution should not exceed 48 hours from the time of preparation to completion of administration. Protect infusion bags from direct sunlight.
2.3 Preparation and Handling Precautions
Do not administer Oncaspar ® if drug has been: • frozen • stored at room temperature 15° to 25°C (59° to 77°F) for more than 48 hours • shaken or vigorously agitated [see How Supplied/Storage and Handling ( 16) ] Parenteral drug products should be inspected visually for particulate matter, cloudiness, or discoloration prior to administration, whenever solution and container permit. If any of these are present, discard the vial.
Adagen

Adagen

Before prescribing ADAGEN® (pegademase bovine) Injection the physician should be thoroughly familiar with the details of this prescribing information. For further information concerning the essential monitoring of ADAGEN® (pegademase bovine) Injection therapy, the prescribing physician should contact Sigma-Tau Pharmaceuticals, Inc., Gaithersburg, MD 20878. Telephone 1-866-792-5172.

ADAGEN® (pegademase bovine) Injection is recommended for use in infants from birth or in children of any age at the time of diagnosis.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.

ADAGEN® (pegademase bovine) Injection should not be diluted nor mixed with any other drug prior to administration.

ADAGEN® (pegademase bovine) Injection should be administered every 7 days as an intramuscular injection. The dosage of ADAGEN® (pegademase bovine) Injection should be individualized. The recommended dosing schedule is 10 U/kg for the first dose, 15 U/kg for the second dose, and 20 U/kg for the third dose. The usual maintenance dose is 20 U/kg per week. Further increases of 5 U/kg/week may be necessary, but a maximum single dose of 30 U/kg should not be exceeded. Plasma levels of ADA more than twice the upper limit of 35 μmol/hr/mL have occurred on occasion in several patients, and have been maintained for several weeks in one patient who received twice weekly injections (20 U/kg per dose) of ADAGEN® (pegademase bovine) Injection. No adverse effects have been observed at these higher levels; there is no evidence that maintaining pre-injection plasma ADA above 35 μmol/hr/mL produces any additional clinical benefits.

Dose proportionality has not been established and patients should be closely monitored when the dosage is increased. ADAGEN® (pegademase bovine) Injection is not recommended for intravenous administration.

The optimal dosage and schedule of administration should be established for each patient based on monitoring of plasma ADA activity levels (trough levels before maintenance injection) and biochemical markers of ADA deficiency (primarily red cell dATP content). Since improvement in immune function follows correction of metabolic abnormalities, maintenance dosage in individual patients should be aimed at achieving the following biochemical goals: 1) maintain plasma ADA activity (trough levels before maintenance injection) in the range of 15-35 μmol/hr/mL (assayed at 37°C); and 2) decline in erythrocyte dATP to ≤ 0.005-0.015 μmol/mL packed erythrocytes, or ≤ 1% of the total erythrocyte adenine nucleotide (ATP + dATP) content, with a normal ATP level, as measured in a pre-injection sample. In addition, continued monitoring of immune function and clinical status is essential in any patient with a primary immunodeficiency disease and should be continued in patients undergoing treatment with ADAGEN® (pegademase bovine) Injection.
Furosemide

Furosemide

CARNITOR® Injection is administered intravenously.

Metabolic Disorders

The recommended dose is 50 mg/kg given as a slow 2-3 minute bolus injection or by infusion. Often a loading dose is given in patients with severe metabolic crisis, followed by an equivalent dose over the following 24 hours. It should be administered q3h or q4h, and never less than q6h either by infusion or by intravenous injection. All subsequent daily doses are recommended to be in the range of 50 mg/kg or as therapy may require. The highest dose administered has been 300 mg/kg.

It is recommended that a plasma carnitine concentration be obtained prior to beginning this parenteral therapy. Weekly and monthly monitoring is recommended as well. This monitoring should include blood chemistries, vital signs, plasma carnitine concentrations (the plasma free carnitine concentration should be between 35 and 60 µmol/L) and overall clinical condition.

ESRD Patients on Hemodialysis

The recommended starting dose is 10-20 mg/kg dry body weight as a slow 2-3 minute bolus injection into the venous return line after each dialysis session. Initiation of therapy may be prompted by trough (pre-dialysis) plasma levocarnitine concentrations that are below normal (40-50 µmol/L). Dose adjustments should be guided by trough (pre-dialysis) levocarnitine concentrations, and downward dose adjustments (e.g. to 5 mg/kg after dialysis) may be made as early as the third or fourth week of therapy.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Carnitor

Carnitor

CARNITOR® (levocarnitine) Tablets.

Adults: The recommended oral dosage for adults is 990 mg two or three times a day using the 330 mg tablets, depending on clinical response.

Infants and children: The recommended oral dosage for infants and children is between 50 and 100 mg/kg/day in divided doses, with a maximum of 3 g/day. Dosage should begin at 50 mg/kg/day. The exact dosage will depend on clinical response.

Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations and overall clinical condition.

CARNITOR® (levocarnitine) Oral Solution and CARNITOR® SF (levocarnitine) Sugar-Free Oral Solution.

For oral use only. Not for parenteral use.

Adults: The recommended dosage of levocarnitine is 1 to 3 g/day for a 50 kg subject, which is equivalent to 10 to 30 mL/day of CARNITOR® (levocarnitine) Oral Solution or CARNITOR® SF (levocarnitine) Sugar-Free Oral Solution. Higher doses should be administered only with caution and only where clinical and biochemical considerations make it seem likely that higher doses will be of benefit. Dosage should start at 1 g/day, (10 mL/day), and be increased slowly while assessing tolerance and therapeutic response. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition.

Infants and children: The recommended dosage of levocarnitine is 50 to 100 mg/kg/day which is equivalent to 0.5 mL/kg/day CARNITOR® (levocarnitine) Oral Solution or CARNITOR® SF (levocarnitine) Sugar-Free Oral Solution. Higher doses should be administered only with caution and only where clinical and biochemical considerations make it seem likely that higher doses will be of benefit. Dosage should start at 50 mg/kg/day, and be increased slowly to a maximum of 3 g/day (30 mL/day) while assessing tolerance and therapeutic response. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition.

CARNITOR® (levocarnitine) Oral Solution or CARNITOR® SF (levocarnitine) Sugar-Free Oral Solution may be consumed alone or dissolved in drink or other liquid food. Doses should be spaced evenly throughout the day (every three or four hours) preferably during or following meals and should be consumed slowly in order to maximize tolerance.
Stribild

Stribild

CARNITOR® (levocarnitine) Tablets.

Adults: The recommended oral dosage for adults is 990 mg two or three times a day using the 330 mg tablets, depending on clinical response.

Infants and children: The recommended oral dosage for infants and children is between 50 and 100 mg/kg/day in divided doses, with a maximum of 3 g/day. Dosage should begin at 50 mg/kg/day. The exact dosage will depend on clinical response.

Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations and overall clinical condition.

CARNITOR® (levocarnitine) Oral Solution and CARNITOR® SF (levocarnitine) Sugar-Free Oral Solution.

For oral use only. Not for parenteral use.

Adults: The recommended dosage of levocarnitine is 1 to 3 g/day for a 50 kg subject, which is equivalent to 10 to 30 mL/day of CARNITOR® (levocarnitine) Oral Solution or CARNITOR® SF (levocarnitine) Sugar-Free Oral Solution. Higher doses should be administered only with caution and only where clinical and biochemical considerations make it seem likely that higher doses will be of benefit. Dosage should start at 1 g/day, (10 mL/day), and be increased slowly while assessing tolerance and therapeutic response. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition.

Infants and children: The recommended dosage of levocarnitine is 50 to 100 mg/kg/day which is equivalent to 0.5 mL/kg/day CARNITOR® (levocarnitine) Oral Solution or CARNITOR® SF (levocarnitine) Sugar-Free Oral Solution. Higher doses should be administered only with caution and only where clinical and biochemical considerations make it seem likely that higher doses will be of benefit. Dosage should start at 50 mg/kg/day, and be increased slowly to a maximum of 3 g/day (30 mL/day) while assessing tolerance and therapeutic response. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition.

CARNITOR® (levocarnitine) Oral Solution or CARNITOR® SF (levocarnitine) Sugar-Free Oral Solution may be consumed alone or dissolved in drink or other liquid food. Doses should be spaced evenly throughout the day (every three or four hours) preferably during or following meals and should be consumed slowly in order to maximize tolerance.

Sigma-tau Pharmaceuticals, Inc.

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Sigma-tau Pharmaceuticals, Inc. Drugs