Spectrum Pharmaceuticals, Inc.

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Spectrum Pharmaceuticals, Inc. Drugs

Fusilev

Fusilev

2.1 Administration Guidelines

Fusilev is dosed at one-half the usual dose of racemic d,l-leucovorin.

Fusilev is indicated for intravenous administration only. Do not administer intrathecally.

2.2 Co-administration of Fusilev with other agents

Due to the risk of precipitation, do not co-administer Fusilev with other agents in the same admixture.

2.3 Fusilev Rescue After High-Dose Methotrexate Therapy

The recommendations for Fusilev rescue are based on a methotrexate dose of 12 grams/m2 administered by intravenous infusion over 4 hours (see methotrexate package insert for full prescribing information). Fusilev rescue at a dose of 7.5 mg (approximately 5 mg/m2) every 6 hours for 10 doses starts 24 hours after the beginning of the methotrexate infusion.

Serum creatinine and methotrexate levels should be determined at least once daily. Fusilev administration, hydration, and urinary alkalinization (pH of 7.0 or greater) should be continued until the methotrexate level is below 5 x 10-8 M (0.05 micromolar). The Fusilev dose should be adjusted or rescue extended based on the following guidelines.
Table 1 Guidelines for Fusilev Dosage and Administration Clinical Situation Laboratory Findings Fusilev Dosage and Duration Normal Methotrexate Elimination Serum methotrexate level approximately 10 micromolar at 24 hours after administration, 1 micromolar at 48 hours, and less than 0.2 micromolar at 72 hours 7.5 mg IV q 6 hours for 60 hours (10 doses starting at 24 hours after start of methotrexate infusion). Delayed Late Methotrexate Elimination Serum methotrexate level remaining above 0.2 micromolar at 72 hours, and more than 0.05 micromolar at 96 hours after administration. Continue 7.5 mg IV q 6 hours, until methotrexate level is less than 0.05 micromolar. Delayed Early Methotrexate Elimination and/or Evidence of Acute Renal Injury Serum methotrexate level of 50 micromolar or more at 24 hours, or 5 micromolar or more at 48 hours after administration, OR; a 100% or greater increase in serum creatinine level at 24 hours after methotrexate administration (e.g., an increase from 0.5 mg/dL to a level of 1 mg/dL or more). 75 mg IV q 3 hours until methotrexate level is less than 1 micromolar; then 7.5 mg IV q 3 hours until methotrexate level is less than 0.05 micromolar.
Patients who experience delayed early methotrexate elimination are likely to develop reversible renal failure. In addition to appropriate Fusilev therapy, these patients require continuing hydration and urinary alkalinization, and close monitoring of fluid and electrolyte status, until the serum methotrexate level has fallen to below 0.05 micromolar and the renal failure has resolved.

Some patients will have abnormalities in methotrexate elimination or renal function following methotrexate administration, which are significant but less severe than the abnormalities described in the table above. These abnormalities may or may not be associated with significant clinical toxicity. If significant clinical toxicity is observed, Fusilev rescue should be extended for an additional 24 hours (total of 14 doses over 84 hours) in subsequent courses of therapy. The possibility that the patient is taking other medications which interact with methotrexate (e.g., medications which may interfere with methotrexate elimination or binding to serum albumin) should always be reconsidered when laboratory abnormalities or clinical toxicities are observed.

Delayed methotrexate excretion may be caused by accumulation in a third space fluid collection (i.e., ascites, pleural effusion), renal insufficiency, or inadequate hydration. Under such circumstances, higher doses of Fusilev or prolonged administration may be indicated.

Although Fusilev may ameliorate the hematologic toxicity associated with high-dose methotrexate, Fusilev has no effect on other established toxicities of methotrexate such as the nephrotoxicity resulting from drug and/or metabolite precipitation in the kidney.

2.4 Dosing Recommendations for Inadvertent Methotrexate Overdosage

Fusilev rescue should begin as soon as possible after an inadvertent overdosage and within 24 hours of methotrexate administration when there is delayed excretion. As the time interval between antifolate administration [e.g., methotrexate] and Fusilev rescue increases, Fusilev’s effectiveness in counteracting toxicity may decrease. Fusilev 7.5 mg (approximately 5 mg/m2 ) should be administered IV every 6 hours until the serum methotrexate level is less than 10-8 M.

Serum creatinine and methotrexate levels should be determined at 24 hour intervals. If the 24 hour serum creatinine has increased 50% over baseline or if the 24 hour methotrexate level is greater than 5 x 10-6 M or the 48 hour level is greater than 9 x 10-7 M, the dose of Fusilev should be increased to 50 mg/m2 IV every 3 hours until the methotrexate level is less than 10-8 M. Hydration (3 L/day) and urinary alkalinization with NaHCO3 should be employed concomitantly. The bicarbonate dose should be adjusted to maintain the urine pH at 7.0 or greater.

2.5 Fusilev Administration in Combination with 5-Fluorouracil (5-FU)

The following regimens have been used historically for the treatment of colorectal cancer:
Fusilev is administered at 100 mg/m2 by slow intravenous injection over a minimum of 3 minutes, followed by 5-FU at 370 mg/m2 by intravenous injection. Fusilev is administered at 10 mg/m2 by intravenous injection followed by 5-FU at 425 mg/m2 by intravenous injection.
5-FU and Fusilev should be administered separately to avoid the formation of a precipitate.

Treatment is repeated daily for five days. This five-day treatment course may be repeated at 4 week (28-day) intervals, for 2 courses and then repeated at 4 to 5 week (28 to 35 day) intervals provided that the patient has completely recovered from the toxic effects of the prior treatment course.

In subsequent treatment courses, the dosage of 5-FU should be adjusted based on patient tolerance of the prior treatment course. The daily dosage of 5-FU should be reduced by 20% for patients who experienced moderate hematologic or gastrointestinal toxicity in the prior treatment course, and by 30% for patients who experienced severe toxicity. For patients who experienced no toxicity in the prior treatment course, 5-FU dosage may be increased by 10%. Fusilev dosages are not adjusted for toxicity.

2.6 Reconstitution and Infusion Instructions

Fusilev for Injection
Prior to intravenous injection, the 50 mg vial of Fusilev for Injection is reconstituted with 5.3 mL of 0.9% Sodium Chloride Injection, USP to yield a levoleucovorin concentration of 10 mg per mL. Reconstitution with Sodium Chloride solutions with preservatives (e.g. benzyl alcohol) has not been studied. The use of solutions other than 0.9% Sodium Chloride Injection, USP is not recommended. The reconstituted 10 mg per mL levoleucovorin contains no preservative. Observe strict aseptic technique during reconstitution of the drug product. Saline reconstituted levoleucovorin solutions may be further diluted, immediately, to concentrations of 0.5 mg/mL to 5 mg/mL in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Initial reconstitution or further dilution using 0.9% Sodium Chloride Injection, USP may be held at room temperature for not more than a total of 12 hours. Dilutions in 5% Dextrose Injection, USP may be held at room temperature for not more than 4 hours. Visually inspect the reconstituted solution for particulate matter and discoloration, prior to administration. CAUTION: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if cloudiness or precipitate is observed. No more than 16 mL of reconstituted solutions (160 mg of levoleucovorin) should be injected intravenously per minute, because of the calcium content of the levoleucovorin solution.
Fusilev Injection
Levoleucovorin contains no preservative. Observe strict aseptic technique during reconstitution of the drug product. Levoleucovorin solutions may be further diluted to concentrations of 0.5 mg/mL in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. The diluted solution using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP may be held at room temperature for not more than 4 hours. Visually inspect the diluted solution for particulate matter and discoloration, prior to administration. CAUTION: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if cloudiness or precipitate is observed. No more than 16 mL of Fusilev Injection (160 mg of levoleucovorin) should be injected intravenously per minute, because of the calcium content of the levoleucovorin solution.
2.5 Fusilev Administration in Combination with 5-Fluorouracil (5-FU)

The following regimens have been used historically for the treatment of colorectal cancer:
Fusilev is administered at 100 mg/m2 by slow intravenous injection over a minimum of 3 minutes, followed by 5-FU at 370 mg/m2 by intravenous injection. Fusilev is administered at 10 mg/m2 by intravenous injection followed by 5-FU at 425 mg/m2 by intravenous injection.
5-FU and Fusilev should be administered separately to avoid the formation of a precipitate.

Treatment is repeated daily for five days. This five-day treatment course may be repeated at 4 week (28-day) intervals, for 2 courses and then repeated at 4 to 5 week (28 to 35 day) intervals provided that the patient has completely recovered from the toxic effects of the prior treatment course.

In subsequent treatment courses, the dosage of 5-FU should be adjusted based on patient tolerance of the prior treatment course. The daily dosage of 5-FU should be reduced by 20% for patients who experienced moderate hematologic or gastrointestinal toxicity in the prior treatment course, and by 30% for patients who experienced severe toxicity. For patients who experienced no toxicity in the prior treatment course, 5-FU dosage may be increased by 10%. Fusilev dosages are not adjusted for toxicity.
Zevalin

Zevalin

Recommended Dosing Schedule:
Administer the Zevalin therapeutic regimen as outlined in Section 2.1. Initiate the Zevalin therapeutic regimen following recovery of platelet counts to ≥150,000/mm3 at least 6 weeks, but no more than 12 weeks, following the last dose of first-line chemotherapy. Only administer Rituxan/Zevalin in facilities where immediate access to resuscitative measures is available.
2.1 Overview of Dosing Schedule

2.2 Zevalin Therapeutic Regimen Dosage and Administration

Day 1:
Premedicate with acetaminophen 650 mg orally and diphenhydramine 50 mg orally prior to rituximab infusion. Administer rituximab 250 mg/m2 intravenously at an initial rate of 50 mg/hr. In the absence of infusion reactions, escalate the infusion rate in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. Do not mix or dilute rituximab with other drugs. Immediately stop the rituximab infusion for serious infusion reactions and discontinue the Zevalin therapeutic regimen [see Boxed Warning and Warnings and Precautions (5.1)]. Temporarily slow or interrupt the rituximab infusion for less severe infusion reactions. If symptoms improve, continue the infusion at one-half the previous rate.
Day 7, 8 or 9:
Premedicate with acetaminophen 650 mg orally and diphenhydramine 50 mg orally prior to rituximab infusion. Administer rituximab 250 mg/m2 intravenously at an initial rate of 100 mg/hr. Increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr, as tolerated. If infusion reactions occurred during rituximab infusion on Day 1 of treatment, administer rituximab at an initial rate of 50 mg/hr and escalate the infusion rate in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. Administer Y-90 Zevalin injection through a free flowing intravenous line within 4 hours following completion of rituximab infusion. Use a 0.22 micron low-protein-binding in-line filter between the syringe and the infusion port. After injection, flush the line with at least 10 mL of normal saline. If platelet count ≥ 150,000/mm3, administer Y-90 Zevalin over 10 minutes as an intravenous injection at a dose of Y-90 0.4 mCi per kg (14.8 MBq per kg) actual body weight. If platelet count ≥ 100,000 but ≤ 149,000/mm3, in relapsed or refractory patients, administer Y-90 Zevalin over 10 minutes as an intravenous injection at a dose of Y-90 0.3 mCi per kg (11.1 MBq per kg) actual body weight. Do not administer more than 32 mCi (1184 MBq) Y-90 Zevalin dose regardless of the patient’s body weight. Monitor patients closely for evidence of extravasation during the injection of Y-90 Zevalin. Immediately stop infusion and restart in another limb if any signs or symptoms of extravasation occur [see Warnings and Precautions (5.6)].
2.3 Directions for Preparation of Radiolabeled Y-90 Zevalin Doses

A clearly-labeled kit is required for preparation of Yttrium-90 (Y-90) Zevalin. Follow the detailed instructions for the preparation of radiolabeled Zevalin [see Dosage and Administration (2.4)].

Required materials not supplied in the kit:
Yttrium-90 Chloride Sterile Solution Three sterile 1 mL plastic syringes One sterile 3 mL plastic syringe Two sterile 10 mL plastic syringes with 18-20 G needles ITLC silica gel strips 0.9% Sodium Chloride aqueous solution for the chromatography solvent Developing chamber for chromatography Suitable radioactivity counting apparatus Filter, 0.22 micrometer, low-protein-binding Appropriate acrylic shielding for reaction vial and syringe for Y-90
Method:
Allow contents of the refrigerated Y-90 Zevalin kit (Zevalin vial, 50 mM sodium acetate vial, and formulation buffer vial) to reach room temperature. Place the empty reaction vial in an appropriate acrylic shield. Determine the amount of each component needed: Calculate volume of Y-90 Chloride equivalent to 40 mCi based on the activity concentration of the Y-90 Chloride stock. The volume of 50 mM Sodium Acetate solution needed is 1.2 times the volume of Y-90 Chloride solution determined in step 3.a, above. Calculate the volume of formulation buffer needed to bring the reaction vial contents to a final volume of 10 mL. Transfer the calculated volume of 50 mM Sodium Acetate to the empty reaction vial. Coat the entire inner surface of the reaction vial by gentle inversion or rolling. Transfer 40 mCi of Y-90 Chloride to the reaction vial using an acrylic shielded syringe. Mix the two solutions by gentle inversion or rolling. Transfer 1.3 mL of Zevalin (ibritumomab tiuxetan) to the reaction vial. Do not shake or agitate the vial contents. Allow the labeling reaction to proceed at room temperature for 5 minutes. A shorter or longer reaction time may adversely alter the final labeled product. Immediately after the 5-minute incubation period, transfer the calculated volume of formulation buffer from step 3.c. to the reaction vial. Gently add the formulation buffer down the side of the reaction vial. If necessary, withdraw an equal volume of air to normalize pressure. Measure the final product for total activity using a radioactivity calibration system suitable for the measurement of Y-90. Using the supplied labels, record the date and time of preparation, the total activity and volume, and the date and time of expiration, and affix these labels to the shielded reaction vial container. Patient Dose: Calculate the volume required for a Y-90 Zevalin dose [see Dosage and Administration (2.2)]. Withdraw the required volume from the reaction vial. Assay the syringe in the dose calibrator suitable for the measurement of Y-90. The measured dose must be within 10% of the prescribed dose of Y-90 Zevalin and must not exceed 32 mCi (1184 MBq). Using the supplied labels, record the patient identifier, total activity and volume and the date and time of expiration, and affix these labels to the syringe and shielded unit dose container. Determine Radiochemical Purity [see Dosage and Administration (2.4)]. Store Yttrium-90 Zevalin at 2-8°C (36-46°F) until use and administer within 8 hours of radiolabeling. Immediately prior to administration, assay the syringe and contents using a radioactivity calibration system suitable for the measurement of Y-90.
2.4 Procedure for Determining Radiochemical Purity

Use the following procedures for radiolabeling Y-90 Zevalin:
Place a small drop of Y-90 Zevalin at the origin of an ITLC silica gel strip. Place the ITLC silica gel strip into a chromatography chamber with the origin at the bottom and the solvent front at the top. Allow the solvent (0.9% NaCl) to migrate at least 5 cm from the bottom of the strip. Remove the strip from the chamber and cut the strip in half. Count each half of the ITLC silica gel strip for one minute (CPM) with a suitable counting apparatus. Calculate the percent RCP as follows: Repeat the ITLC procedure if the radiochemical purity is <95%. If repeat testing confirms that radiochemical purity is <95%, do not administer the Y-90 Zevalin dose.
2.5 Radiation Dosimetry

During clinical trials with Zevalin, estimations of radiation-absorbed doses for Y-90 Zevalin were performed using sequential whole body images and the MIRDOSE 3 software program. The estimated radiation absorbed doses to organs and marrow from a course of the Zevalin therapeutic regimen are summarized in Table 1. Absorbed dose estimates for the lower large intestine, upper large intestine, and small intestine have been modified from the standard MIRDOSE 3 output to account for the assumption that activity is within the intestine wall rather than the intestine contents.
Table 1. Estimated Radiation Absorbed Doses from Y-90 Zevalin * Organ region of interest † Sacrum region of interest ‡ Whole body region of interest Organ Y-90 Zevalin cGy /mCi (mGy/MBq) Median Range Spleen* 34.78 (9.4) 6.66 - 74.00 (1.8 - 20.0) Liver* 17.76 (4.8) 10.73 - 29.97 (2.9 - 8.1) Lower Large Intestinal Wall* 17.39 (4.7) 11.47 - 30.34 (3.1 - 8.2) Upper Large Intestinal Wall* 13.32 (3.6) 7.40 - 24.79 (2.0 - 6.7) Heart Wall* 10.73 (2.9) 5.55 - 11.84 (1.5 - 3.2) Lungs* 7.4 (2) 4.44 - 12.58 (1.2 -3.4) Testes* 5.55 (1.5) 3.70 - 15.91 (1.0 - 4.3) Small Intestine* 5.18 (1.4) 2.96 - 7.77 (0.8 - 2.1) Red Marrow† 4.81 (1.3) 2.22 - 6.66 (0.6 - 1.8) Urinary Bladder Wall‡ 3.33 (0.9) 2.59 - 4.81 (0.7 - 1.3) Bone Surfaces† 3.33 (0.9) 1.85 - 4.44 (0.5 - 1.2) Total Body‡ 1.85 (0.5) 1.48 - 2.59 (0.4 - 0.7) Ovaries‡ 1.48 (0.4) 1.11 - 1.85 (0.3 - 0.5) Uterus‡ 1.48 (0.4) 1.11 - 1.85 (0.3 - 0.5) Adrenals‡ 1.11 (0.3) 0.74 - 1.85 (0.2 - 0.5) Brain‡ 1.11 (0.3) 0.74 - 1.85 (0.2 - 0.5) Breasts‡ 1.11 (0.3) 0.74 - 1.85 (0.2 - 0.5) Gallbladder Wall‡ 1.11 (0.3) 0.74 - 1.85 (0.2 - 0.5) Muscle‡ 1.11 (0.3) 0.74 - 1.85 (0.2 - 0.5) Pancreas‡ 1.11 (0.3) 0.74 - 1.85 (0.2 - 0.5) Skin‡ 1.11 (0.3) 0.74 - 1.85 (0.2 - 0.5) Stomach‡ 1.11 (0.3) 0.74 - 1.85 (0.2 - 0.5) Thymus‡ 1.11 (0.3) 0.74 - 1.85 (0.2 - 0.5) Thyroid‡ 1.11 (0.3) 0.74 - 1.85 (0.2 - 0.5) Kidneys* 0.37 (0.1) 0.00 - 1.11 (0.0 - 0.3)
Beleodaq

Beleodaq

2.1 Dosing Information

The recommended dosage of Beleodaq is 1,000 mg/m2 administered over 30 minutes by intravenous infusion once daily on Days 1-5 of a 21-day cycle. Cycles can be repeated every 21 days until disease progression or unacceptable toxicity.

2.2 Dosage Modification for Hematologic and Non-Hematologic Toxicities

Table 1 displays the recommended Beleodaq dosage modifications for hematologic and non-hematologic toxicities. Base dosage adjustments for thrombocytopenia and neutropenia on platelet and absolute neutrophil nadir (lowest value) counts in the preceding cycle of therapy.
• Absolute neutrophil count (ANC) should be greater than or equal to 1.0 x 10 9/L and the platelet count should be greater than or equal to 50 x 10 9/L prior to the start of each cycle and prior to resuming treatment following toxicity. Resume subsequent treatment with Beleodaq according to the guidelines described in Table 1 below. Discontinue Beleodaq in patients who have recurrent ANC nadirs less than 0.5 x 10 9/L and/or recurrent platelet count nadirs less than 25 x 10 9/L after two dosage reductions. • Other toxicities must be NCI-CTCAE Grade 2 or less prior to re-treatment.
Monitor complete blood counts at baseline and weekly. Perform serum chemistry tests, including renal and hepatic functions prior to the start of the first dose of each cycle.
Table 1: Dosage Modifications for Hematologic and Non-Hematologic Toxicities * For nausea, vomiting, and diarrhea, only dose modify if the duration is greater than 7 days with supportive management
Dosage Modification

Dosage Modifications due to Hematologic Toxicities

   Platelet count ≥ 25 x 109/L and nadir ANC ≥ 0.5 x 109/L

No Change

   Nadir ANC < 0.5 x 109/L (any platelet count)

Decrease dosage by 25% (750 mg/m2)

   Platelet count < 25 x 109/L (any nadir ANC)

Dosage Modifications due to Non-Hematologic Toxicities

   Any CTCAE Grade 3 or 4 adverse reaction*

Decrease dosage by 25% (750 mg/m2)

   Recurrence of CTCAE Grade 3 or 4 adverse reaction after two dosage reductions

Discontinue Beleodaq

2.3 Patients with Reduced UGT1A1 Activity

Reduce the starting dose of Beleodaq to 750 mg/m2 in patients known to be homozygous for the UGT1A1*28 allele [see Clinical Pharmacology (12.5)].

2.4 Preparation and Administration Precautions

As with other potentially cytotoxic anticancer agents, exercise care in the handling and preparation of solutions prepared with Beleodaq.

2.5 Reconstitution and Infusion Instructions
a) Aseptically reconstitute each vial of Beleodaq by adding 9 mL of Sterile Water for injection, USP, into the Beleodaq vial with a suitable syringe to achieve a concentration of 50 mg of belinostat per mL. Swirl the contents of the vial until there are no visible particles in the resulting solution. The reconstituted product may be stored for up to 12 hours at ambient temperature (15-25°C; 59-77°F). b) Aseptically withdraw the volume needed for the required dosage (based on the 50 mg/mL concentration and the patient’s BSA [m 2]) and transfer to an infusion bag containing 250 mL of 0.9 % Sodium Chloride injection. The infusion bag with drug solution may be stored at ambient room temperature (15-25°C; 59-77°F) for up to 36 hours including infusion time. c) Visually inspect the solution for particulate matter. Do not use if cloudiness or particulates are observed. d) Connect the infusion bag containing drug solution to an infusion set with a 0.22 µm in-line filter for administration. e) Infuse intravenously over 30 minutes. If infusion site pain or other symptoms potentially attributable to the infusion occur, the infusion time may be extended to 45 minutes.
2.1 Dosing Information

The recommended dosage of Beleodaq is 1,000 mg/m2 administered over 30 minutes by intravenous infusion once daily on Days 1-5 of a 21-day cycle. Cycles can be repeated every 21 days until disease progression or unacceptable toxicity.

2.2 Dosage Modification for Hematologic and Non-Hematologic Toxicities

Table 1 displays the recommended Beleodaq dosage modifications for hematologic and non-hematologic toxicities. Base dosage adjustments for thrombocytopenia and neutropenia on platelet and absolute neutrophil nadir (lowest value) counts in the preceding cycle of therapy.
• Absolute neutrophil count (ANC) should be greater than or equal to 1.0 x 10 9/L and the platelet count should be greater than or equal to 50 x 10 9/L prior to the start of each cycle and prior to resuming treatment following toxicity. Resume subsequent treatment with Beleodaq according to the guidelines described in Table 1 below. Discontinue Beleodaq in patients who have recurrent ANC nadirs less than 0.5 x 10 9/L and/or recurrent platelet count nadirs less than 25 x 10 9/L after two dosage reductions. • Other toxicities must be NCI-CTCAE Grade 2 or less prior to re-treatment.
Monitor complete blood counts at baseline and weekly. Perform serum chemistry tests, including renal and hepatic functions prior to the start of the first dose of each cycle.
Table 1: Dosage Modifications for Hematologic and Non-Hematologic Toxicities * For nausea, vomiting, and diarrhea, only dose modify if the duration is greater than 7 days with supportive management
Dosage Modification

Dosage Modifications due to Hematologic Toxicities

   Platelet count ≥ 25 x 109/L and nadir ANC ≥ 0.5 x 109/L

No Change

   Nadir ANC < 0.5 x 109/L (any platelet count)

Decrease dosage by 25% (750 mg/m2)

   Platelet count < 25 x 109/L (any nadir ANC)

Dosage Modifications due to Non-Hematologic Toxicities

   Any CTCAE Grade 3 or 4 adverse reaction*

Decrease dosage by 25% (750 mg/m2)

   Recurrence of CTCAE Grade 3 or 4 adverse reaction after two dosage reductions

Discontinue Beleodaq

2.3 Patients with Reduced UGT1A1 Activity

Reduce the starting dose of Beleodaq to 750 mg/m2 in patients known to be homozygous for the UGT1A1*28 allele [see Clinical Pharmacology (12.5)].

2.4 Preparation and Administration Precautions

As with other potentially cytotoxic anticancer agents, exercise care in the handling and preparation of solutions prepared with Beleodaq.

2.5 Reconstitution and Infusion Instructions
a) Aseptically reconstitute each vial of Beleodaq by adding 9 mL of Sterile Water for injection, USP, into the Beleodaq vial with a suitable syringe to achieve a concentration of 50 mg of belinostat per mL. Swirl the contents of the vial until there are no visible particles in the resulting solution. The reconstituted product may be stored for up to 12 hours at ambient temperature (15-25°C; 59-77°F). b) Aseptically withdraw the volume needed for the required dosage (based on the 50 mg/mL concentration and the patient’s BSA [m 2]) and transfer to an infusion bag containing 250 mL of 0.9 % Sodium Chloride injection. The infusion bag with drug solution may be stored at ambient room temperature (15-25°C; 59-77°F) for up to 36 hours including infusion time. c) Visually inspect the solution for particulate matter. Do not use if cloudiness or particulates are observed. d) Connect the infusion bag containing drug solution to an infusion set with a 0.22 µm in-line filter for administration. e) Infuse intravenously over 30 minutes. If infusion site pain or other symptoms potentially attributable to the infusion occur, the infusion time may be extended to 45 minutes.

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Spectrum Pharmaceuticals, Inc. Drugs