Celgene Corporation

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Celgene Corporation Drugs

Innohep

Innohep

All patients should be evaluated for bleeding disorders before administration of INNOHEP®. Since coagulation parameters are unsuitable for monitoring INNOHEP® activity, routine monitoring of coagulation parameters is not required (see PRECAUTIONS, Laboratory Tests).

Adult Dosage

The recommended dose of INNOHEP® for the treatment of DVT with or without PE is 175 anti-Xa IU/kg of body weight, administered SC once daily for at least 6 days and until the patient is adequately anticoagulated with warfarin (INR at least 2.0 for two consecutive days). Warfarin sodium therapy should be initiated when appropriate (usually within 1-3 days of INNOHEP® initiation). Pregnancy has little or no influence on the pharmacokinetics of INNOHEP® and no dosing adjustment is needed for pregnancy.

As INNOHEP® may theoretically affect the PT/INR, patients receiving both INNOHEP® and warfarin should have blood for PT/INR determination drawn just prior to the next scheduled dose of INNOHEP®.

Table 8 provides INNOHEP® doses for the treatment of DVT with or without PE. It is necessary to calculate the appropriate INNOHEP® dose for patient weights not displayed in Table 8.

An appropriately calibrated syringe should be used to assure withdrawal of the correct volume of drug from INNOHEP® vials.
Table 8 INNOHEP® Weight-based Dosing for Treatment of Deep Vein Thrombosis With or Without Symptomatic Pulmonary Embolism DVT Treatment Patient Body Weight in Pounds 175 IU/kg SC Once Daily 20,000 IU per mL Patient Body Weight inKilograms Dose (IU) Amount (mL) 68-80 6,000 0.3 31-36 81-94 7,000 0.35 37-42 95-107 8,000 0.4 43-48 108-118 9,000 0.45 49-53 119-131 10,000 0.5 54-59 132-144 11,000 0.55 60-65 145-155 12,000 0.6 66-70 156-168 13,000 0.65 71-76 169-182 14,000 0.7 77-82 183-195 15,000 0.75 83-88 196-206 16,000 0.8 89-93 207-219 17,000 0.85 94-99 220-232 18,000 0.9 100-105 233-243 19,000 0.95 106-110 244-256 20,000 1 111-116 257-270 21,000 1.05 117-122 271-283 22,000 1.1 123-128 284-294 23,000 1.15 129-133 295-307 24,000 1.2 134-139 308-320 25,000 1.25 140-145 321-331 26,000 1.3 146-150 332-344 27,000 1.35 151-156 345-358 28,000 1.4 157-162
To calculate the volume (mL) of an INNOHEP® 175 anti-Xa IU per kg SC dose for treatment of deep vein thrombosis:
Patient weight (kg) X 0.00875 mL/kg = volume to be administered (mL) subcutaneously
Administration

INNOHEP® is a clear, colorless to slightly yellow solution, and as with other parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

INNOHEP® is administered by SC injection. It must not be administered by intramuscular or intravenous injection.

Subcutaneous Injection Technique: Patients should be lying down (supine) or sitting and INNOHEP® administered by deep SC injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. The injection site should be varied daily. The whole length of the needle should be introduced into a skin fold held between the thumb and forefinger; the skin fold should be held throughout the injection. To minimize bruising, do not rub the injection site after completion of the injection.
Istodax

Istodax

2.1 Dosing Information

The recommended dose of romidepsin is 14 mg/m2 administered intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle. Cycles should be repeated every 28 days provided that the patient continues to benefit from and tolerates the drug.

2.2 Dose Modification

Nonhematologic toxicities except alopecia
Grade 2 or 3 toxicity: Treatment with romidepsin should be delayed until toxicity returns to ≤ Grade 1 or baseline, then therapy may be restarted at 14 mg/m2. If Grade 3 toxicity recurs, treatment with romidepsin should be delayed until toxicity returns to ≤ Grade 1 or baseline and the dose should be permanently reduced to 10 mg/m2. Grade 4 toxicity: Treatment with romidepsin should be delayed until toxicity returns to ≤ Grade 1 or baseline, then the dose should be permanently reduced to 10 mg/m2. Romidepsin should be discontinued if Grade 3 or 4 toxicities recur after dose reduction.
Hematologic toxicities
Grade 3 or 4 neutropenia or thrombocytopenia: Treatment with romidepsin should be delayed until the specific cytopenia returns to ANC ≥1.5×109/L and platelet count ≥75×109/L or baseline, then therapy may be restarted at 14 mg/m2. Grade 4 febrile (≥ 38.5ºC) neutropenia or thrombocytopenia that requires platelet transfusion: Treatment with romidepsin should be delayed until the specific cytopenia returns to ≤ Grade 1 or baseline, and then the dose should be permanently reduced to 10 mg/m2.
2.3 Instructions for Preparation and Intravenous Administration

ISTODAX is a cytotoxic drug. Use appropriate handling procedures.

ISTODAX must be reconstituted with the supplied diluent and further diluted with 0.9% Sodium Chloride Injection, USP before intravenous infusion.
Each 10 mg single-use vial of ISTODAX (romidepsin) must be reconstituted with 2 mL of the supplied diluent. With a suitable syringe, aseptically withdraw 2 mL from the supplied diluent vial, and slowly inject it into the ISTODAX (romidepsin) for injection vial. Swirl the contents of the vial until there are no visible particles in the resulting solution. The reconstituted solution will contain ISTODAX 5 mg/mL. The reconstituted ISTODAX solution is chemically stable for up to 8 hours at room temperature. Extract the appropriate amount of ISTODAX from the vials to deliver the desired dose, using proper aseptic technique. Before intravenous infusion, further dilute ISTODAX in 500 mL 0.9% Sodium Chloride Injection, USP. Infuse over 4 hours.
The diluted solution is compatible with polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), polyethylene (PE) infusion bags as well as glass bottles, and is chemically stable for up to 24 hours when stored at room temperature. However, it should be administered as soon after dilution as possible.

Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit.
Atorvastatin Calcium

Atorvastatin Calcium

THALOMID® (THALIDOMIDE) MUST ONLY BE ADMINISTERED IN COMPLIANCE WITH ALL OF THE TERMS OUTLINED IN THE THALOMID REMS PROGRAM. THALOMID® (THALIDOMIDE) MAY ONLY BE PRESCRIBED BY PRESCRIBERS CERTIFIED WITH THE THALOMID REMS PROGRAM AND MAY ONLY BE DISPENSED BY PHARMACISTS CERTIFIED WITH THE THALOMID REMS PROGRAM.

Drug prescribing to females of reproductive potential should be contingent upon initial and continued confirmed negative results of pregnancy testing.

Consider dose reduction, delay, or discontinuation in patients who develop NCI CTC (National Cancer Institute Common Toxicity Criteria) Grade 3 or 4 adverse reactions and/or based on clinical judgment.

2.1 Multiple Myeloma

THALOMID is administered in combination with dexamethasone in 28-day treatment cycles. The dose of THALOMID is 200 mg administered orally once daily with water, preferably at bedtime and at least 1 hour after the evening meal. The dose of dexamethasone is 40 mg daily administered orally on days 1-4, 9-12, and 17-20 every 28 days.

Patients who develop adverse reactions such as constipation, somnolence, or peripheral neuropathy may benefit by either temporarily discontinuing the drug or continuing at a lower dose. With the abatement of these adverse reactions, the drug may be started at a lower dose or at the previous dose based on clinical judgment.

2.2 Erythema Nodosum Leprosum

For an episode of cutaneous ENL, THALOMID dosing should be initiated at 100 to 300 mg/day, administered once daily with water, preferably at bedtime and at least 1 hour after the evening meal. Patients weighing less than 50 kilograms should be started at the low end of the dose range.

In patients with a severe cutaneous ENL reaction, or in those who have previously required higher doses to control the reaction, THALOMID dosing may be initiated at higher doses up to 400 mg/day once daily at bedtime or in divided doses with water, at least 1 hour after meals.

In patients with moderate to severe neuritis associated with a severe ENL reaction, corticosteroids may be started concomitantly with THALOMID. Steroid usage can be tapered and discontinued when the neuritis has ameliorated.

Dosing with THALOMID should usually continue until signs and symptoms of active reaction have subsided, usually a period of at least 2 weeks. Patients may then be tapered off medication in 50 mg decrements every 2 to 4 weeks.

Patients who have a documented history of requiring prolonged maintenance treatment to prevent the recurrence of cutaneous ENL or who flare during tapering should be maintained on the minimum dose necessary to control the reaction. Tapering off medication should be attempted every 3 to 6 months, in decrements of 50 mg every 2 to 4 weeks.
Pomalyst

Pomalyst

2.1 Multiple Myeloma

Females of reproductive potential must have negative pregnancy testing and use contraception methods before initiating POMALYST [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6)].

The recommended starting dose of POMALYST is 4 mg once daily orally on Days 1-21 of repeated 28-day cycles until disease progression. POMALYST should be given in combination with dexamethasone [see Clinical Studies (14.1)].

POMALYST may be taken with water. Inform patients not to break, chew, or open the capsules. POMALYST should be taken without food (at least 2 hours before or 2 hours after a meal).

2.2 Dose Adjustments for Toxicities
Table 1: Dose Modification Instructions for POMALYST for Hematologic Toxicities ANC, absolute neutrophil count Toxicity Dose Modification Neutropenia ANC <500 per mcL or febrile neutropenia (fever more than or equal to 38.5°C and ANC <1,000 per mcL) ANC return to more than or equal to 500 per mcL Interrupt POMALYST treatment, follow CBC weekly Resume POMALYST treatment at 3 mg daily For each subsequent drop <500 per mcL Return to more than or equal to 500 per mcL Interrupt POMALYST treatment Resume POMALYST treatment at 1 mg less than the previous dose Thrombocytopenia Platelets <25,000 per mcL Platelets return to >50,000 per mcL Interrupt POMALYST treatment, follow CBC weekly Resume POMALYST treatment at 3 mg daily For each subsequent drop <25,000 per mcL Return to more than or equal to 50,000 per mcL Interrupt POMALYST treatment Resume POMALYST treatment at 1 mg less than previous dose
To initiate a new cycle of POMALYST, the neutrophil count must be at least 500 per mcL and the platelet count must be at least 50,000 per mcL. If toxicities occur after dose reductions to 1 mg, then discontinue POMALYST.

Permanently discontinue POMALYST for angioedema, skin exfoliation, bullae, or any other severe dermatologic reaction [see Warnings and Precautions (5.6)].

For other Grade 3 or 4 toxicities, hold treatment and restart treatment at 1 mg less than the previous dose when toxicity has resolved to less than or equal to Grade 2 at the physician’s discretion.

2.3 Dose Adjustment for Strong CYP1A2 Inhibitors in the Presence of Strong CYP3A4 and P-gp Inhibitors

Avoid co-administration of strong inhibitors of CYP1A2. If necessary to co-administer strong inhibitors of CYP1A2 in the presence of strong inhibitors of CYP3A4 and P-gp, reduce POMALYST dose by 50%. No clinical efficacy or safety data exist [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
Revlimid

Revlimid

REVLIMID should be taken orally at about the same time each day, either with or without food. REVLIMID capsules should be swallowed whole with water. The capsules should not be opened, broken, or chewed.

2.1 Multiple Myeloma

Multiple Myeloma

The recommended starting dose of REVLIMID is 25 mg orally once daily on Days 1-21 of repeated 28-day cycles in combination with dexamethasone. Refer to Section 14.1 for specific dexamethasone dosing. For patients > 75 years old, the starting dose of dexamethasone may be reduced [see Clinical Studies (14.1)]. Treatment should be continued until disease progression or unacceptable toxicity.

In patients who are not eligible for autologous stem cell transplantation (ASCT), treatment should continue until disease progression or unacceptable toxicity. For patients who are ASCT-eligible, hematopoietic stem cell mobilization should occur within 4 cycles of a REVLIMID-containing therapy [see Warnings and Precautions (5.11)].

Dose Adjustments for Hematologic Toxicities During Multiple Myeloma Treatment

Dose modification guidelines, as summarized in Table 1 below, are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to REVLIMID.

Table 1: Dose Adjustments for Hematologic Toxicities for MM

Platelet counts

Thrombocytopenia in MM
When Platelets Recommended Course Fall to <30,000/mcL Interrupt REVLIMID treatment, follow CBC weekly Return to ≥30,000/mcL Resume REVLIMID at next lower dose. Do not dose below 2.5 mg daily For each subsequent drop <30,000/mcL Interrupt REVLIMID treatment Return to ≥30,000/mcL Resume REVLIMID at next lower dose. Do not dose below 2.5 mg daily
Absolute Neutrophil counts (ANC)

Neutropenia in MM
When Neutrophils Recommended Course Fall to <1000/mcL Interrupt REVLIMID treatment, follow CBC weekly Return to ≥1,000/mcL and neutropenia is the only toxicity Resume REVLIMID at 25 mg daily or initial starting dose Return to ≥1,000/mcL and if other toxicity Resume REVLIMID at next lower dose. Do not dose below 2.5 mg daily For each subsequent drop <1,000/mcL Interrupt REVLIMID treatment Return to ≥1,000/mcL Resume REVLIMID at next lower dose. Do not dose below 2.5 mg daily
Other Toxicities in MM

For other Grade 3/4 toxicities judged to be related to REVLIMID, hold treatment and restart at the physician's discretion at next lower dose level when toxicity has resolved to ≤ Grade 2.

Starting Dose Adjustment for Renal Impairment in MM:

[See Dosage and Administration (2.4)].

2.2 Myelodysplastic Syndromes

The recommended starting dose of REVLIMID is 10 mg daily. Treatment is continued or modified based upon clinical and laboratory findings.

Dose Adjustments for Hematologic Toxicities During MDS Treatment

Patients who are dosed initially at 10 mg and who experience thrombocytopenia should have their dosage adjusted as follows:

Platelet counts

If thrombocytopenia develops WITHIN 4 weeks of starting treatment at 10 mg daily in MDS
If baseline ≥100,000/mcL When Platelets Recommended Course Fall to <50,000/mcL Interrupt REVLIMID treatment Return to ≥50,000/mcL Resume REVLIMID at 5 mg daily If baseline <100,000/mcL When Platelets Recommended Course Fall to 50% of the baseline value Interrupt REVLIMID treatment If baseline ≥60,000/mcL andreturns to ≥50,000/mcL Resume REVLIMID at 5 mg daily If baseline <60,000/mcL andreturns to ≥30,000/mcL Resume REVLIMID at 5 mg daily
If thrombocytopenia develops AFTER 4 weeks of starting treatment at 10 mg daily in MDS
When Platelets Recommended Course <30,000/mcL or <50,000/mcLwith platelet transfusions Interrupt REVLIMID treatment Return to ≥30,000/mcL(without hemostatic failure) Resume REVLIMID at 5 mg daily
Patients who experience thrombocytopenia at 5 mg daily should have their dosage adjusted as follows:

If thrombocytopenia develops during treatment at 5 mg daily in MDS
When Platelets Recommended Course <30,000/mcL or <50,000/mcLwith platelet transfusions Interrupt REVLIMID treatment Return to ≥30,000/mcL(without hemostatic failure) Resume REVLIMID at 2.5 mg daily
Patients who are dosed initially at 10 mg and experience neutropenia should have their dosage adjusted as follows:

Absolute Neutrophil counts (ANC)

If neutropenia develops WITHIN 4 weeks of starting treatment at 10 mg daily in MDS
If baseline ANC ≥1,000/mcL When Neutrophils Recommended Course Fall to <750/mcL Interrupt REVLIMID treatment Return to ≥1,000/mcL Resume REVLIMID at 5 mg daily If baseline ANC <1,000/mcL When Neutrophils Recommended Course Fall to <500/mcL Interrupt REVLIMID treatment Return to ≥500/mcL Resume REVLIMID at 5 mg daily
If neutropenia develops AFTER 4 weeks of starting treatment at 10 mg daily in MDS
When Neutrophils Recommended Course <500/mcL for ≥7 days or <500/mcLassociated with fever (≥38.5°C) Interrupt REVLIMID treatment Return to ≥500/mcL Resume REVLIMID at 5 mg daily
Patients who experience neutropenia at 5 mg daily should have their dosage adjusted as follows:

If neutropenia develops during treatment at 5 mg daily in MDS
When Neutrophils Recommended Course <500/mcL for ≥7 days or <500/mcLassociated with fever (≥38.5°C) Interrupt REVLIMID treatment Return to ≥500/mcL Resume REVLIMID at 2.5 mg daily
Other Grade 3 / 4 Toxicities in MDS

For other Grade 3/4 toxicities judged to be related to REVLIMID, hold treatment and restart at the physician's discretion at next lower dose level when toxicity has resolved to ≤ Grade 2.

Starting Dose Adjustment for Renal Impairment in MDS:

[See Dosage and Administration (2.4)].

2.3 Mantle Cell Lymphoma

The recommended starting dose of REVLIMID is 25 mg/day orally on Days 1-21 of repeated 28-day cycles for relapsed or refractory mantle cell lymphoma. Treatment should be continued until disease progression or unacceptable toxicity.

Treatment is continued, modified or discontinued based upon clinical and laboratory findings.

Dose Adjustments for Hematologic Toxicities During MCL Treatment

Dose modification guidelines as summarized below are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicities considered to be related to REVLIMID.

Platelet counts

Thrombocytopenia during treatment in MCL
When Platelets Recommended Course Fall to <50,000/mcL Interrupt REVLIMID treatment and followCBC weekly Return to ≥50,000/mcL Resume REVLIMID at 5 mg less than theprevious dose. Do not dose below 5 mg daily
Absolute Neutrophil counts (ANC)

Neutropenia during treatment in MCL
When Neutrophils Recommended Course Fall to <1000/mcL for at least 7 daysORFalls to < 1,000/mcL with an associated temperature ≥ 38.5°CORFalls to < 500 /mcL Interrupt REVLIMID treatment and followCBC weekly Return to ≥1,000/mcL Resume REVLIMID at 5 mg less than theprevious dose. Do not dose below 5 mg daily
Other Grade 3 / 4 Toxicities in MCL

For other Grade 3/4 toxicities judged to be related to REVLIMID, hold treatment and restart at the physician’s discretion at next lower dose level when toxicity has resolved to ≤ Grade 2.

Starting Dose Adjustment for Renal Impairment in MCL:

[See Dosage and Administration (2.4)].

2.4 Starting Dose for Renal Impairment in MM, MDS or MCL

Since REVLIMID is primarily excreted unchanged by the kidney, adjustments to the starting dose of REVLIMID are recommended to provide appropriate drug exposure in patients with moderate or severe renal impairment and in patients on dialysis. Based on a pharmacokinetic study in patients with renal impairment due to non-malignant conditions, REVLIMID starting dose adjustment is recommended for patients with CLcr < 60 mL/min. The recommendations for initial starting doses for patients with MDS or MCL, and MM are as follows:
Table 2: Starting Dose Adjustments for Patients with Renal Impairment in MDS or MCL Category Renal Function (Cockcroft-Gault) Dose in MCL Dose in MDS Moderate RenalImpairment CLcr 30-60 mL/min 10 mgEvery 24 hours 5 mgEvery 24 hours Severe Renal Impairment CLcr < 30 mL/min (notrequiring dialysis) 15 mgEvery 48 hours 2.5 mgEvery 24 hours End Stage Renal Disease CLcr < 30 mL/min (requiringdialysis) 5 mgOnce daily. On dialysisdays, administer the dosefollowing dialysis. 2.5 mgOnce daily. On dialysis days,administer the dose followingdialysis. Table 3: Starting Dose Adjustments for Patients with Renal Impairment in MM Category Renal Function (Cockcroft-Gault) Dose in MM Moderate RenalImpairment CLcr 30-50 mL/min 10 mgEvery 24 hours Severe Renal Impairment CLcr < 30 mL/min (notrequiring dialysis) 15 mgEvery 48 hours End Stage Renal Disease CLcr < 30 mL/min (requiringdialysis) 5 mgOnce daily. On dialysisdays, administer the dosefollowing dialysis.
Moderate renal impairment for MM: Consider escalating the dose to 15 mg after 2 cycles if the patient tolerates the 10 mg dose of lenalidomide without dose-limiting toxicity.

After initiation of REVLIMID therapy, subsequent REVLIMID dose increase or decrease is based on individual patient treatment tolerance, as described elsewhere [See Dosage and Administration (2.1-2.3)].
Ceftin

Ceftin

2.1 First Treatment Cycle

The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days. Patients should be premedicated for nausea and vomiting.

Complete blood counts, liver chemistries and serum creatinine should be obtained prior to first dose.

2.2 Subsequent Treatment Cycles

Cycles should be repeated every 4 weeks. The dose may be increased to 100 mg/m2 if no beneficial effect is seen after 2 treatment cycles and if no toxicity other than nausea and vomiting has occurred. It is recommended that patients be treated for a minimum of 4 to 6 cycles. However, complete or partial response may require additional treatment cycles. Treatment may be continued as long as the patient continues to benefit.

Patients should be monitored for hematologic response and renal toxicities [see Warnings and Precautions (5.3)], and dosage delay or reduction as described below may be necessary.

2.3 Dosage Adjustment Based on Hematology Laboratory Values
For patients with baseline (start of treatment) WBC ≥3.0 x109/L, ANC ≥1.5 x109/L, and platelets ≥75.0 x109/L, adjust the dose as follows, based on nadir counts for any given cycle: Nadir Counts % Dose in the NextCourse ANC (x109/L) <0.50.5 –1.5>1.5 Platelets (x109/L) <25.025.0-50.0>50.0 50%67%100% For patients whose baseline counts are WBC <3.0 x109/L, ANC<1.5 x109/L, or platelets <75.0 x109/L, dose adjustments should be based on nadir counts and bone marrow biopsy cellularity at the time of the nadir as noted below, unless there is clear improvement in differentiation (percentage of mature granulocytes is higher and ANC is higher than at onset of that course) at the time of the next cycle, in which case the dose of the current treatment should be continued. WBC or PlateletNadir% decrease incountsfrom baseline Bone MarrowBiopsy Cellularity at Time of Nadir(%) 30-60 15-30 <15 % Dose in the Next Course 50 - 75 100 50 33 >75 75 50 33
If a nadir as defined in the table above has occurred, the next course of treatment should be given 28 days after the start of the preceding course, provided that both the WBC and the platelet counts are >25% above the nadir and rising. If a >25% increase above the nadir is not seen by day 28, counts should be reassessed every 7 days. If a 25% increase is not seen by day 42, then the patient should be treated with 50% of the scheduled dose.

2.4 Dosage Adjustment Based on Serum Electrolytes and Renal Toxicity

If unexplained reductions in serum bicarbonate levels to <20 mEq/L occur, the dosage should be reduced by 50% on the next course. Similarly, if unexplained elevations of BUN or serum creatinine occur, the next cycle should be delayed until values return to normal or baseline and the dose should be reduced by 50% on the next treatment course [see Warnings and Precautions (5.3)].

2.5 Use in Geriatric Patients

Azacitidine and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Warnings and Precautions (5.3) and Use in Specific Populations (8.5)].

2.6 Preparation of VIDAZA

VIDAZA is a cytotoxic drug and, as with other potentially toxic compounds, caution should be exercised when handling and preparing VIDAZA suspensions [see How Supplied/Storage and Handling (16)].

If reconstituted VIDAZA comes into contact with the skin, immediately and thoroughly wash with soap and water. If it comes into contact with mucous membranes, flush thoroughly with water.

The VIDAZA vial is single-use and does not contain any preservatives. 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.

2.7 Instructions for Subcutaneous Administration

VIDAZA should be reconstituted aseptically with 4 mL sterile water for injection. The diluent should be injected slowly into the vial. Vigorously shake or roll the vial until a uniform suspension is achieved. The suspension will be cloudy. The resulting suspension will contain azacitidine 25 mg/mL. Do not filter the suspension after reconstitution. Doing so could remove the active substance.

Preparation for Immediate Subcutaneous Administration: Doses greater than 4 mL should be divided equally into 2 syringes. The product may be held at room temperature for up to 1 hour, but must be administered within 1 hour after reconstitution.

Preparation for Delayed Subcutaneous Administration: The reconstituted product may be kept in the vial or drawn into a syringe. Doses greater than 4 mL should be divided equally into 2 syringes. The product must be refrigerated immediately. When VIDAZA is reconstituted using water for injection that has not been refrigerated, the reconstituted product may be held under refrigerated conditions (2ºC - 8ºC, 36ºF - 46ºF) for up to 8 hours. When VIDAZA is reconstituted using refrigerated (2ºC - 8ºC, 36ºF - 46ºF) water for injection, the reconstituted product may be stored under refrigerated conditions (2ºC - 8ºC, 36ºF - 46ºF) for up to 22 hours. After removal from refrigerated conditions, the suspension may be allowed to equilibrate to room temperature for up to 30 minutes prior to administration.

Subcutaneous Administration

To provide a homogeneous suspension, the contents of the dosing syringe must be re-suspended immediately prior to administration. To re-suspend, vigorously roll the syringe between the palms until a uniform, cloudy suspension is achieved.

VIDAZA suspension is administered subcutaneously. Doses greater than 4 mL should be divided equally into 2 syringes and injected into 2 separate sites. Rotate sites for each injection (thigh, abdomen, or upper arm). New injections should be given at least one inch from an old site and never into areas where the site is tender, bruised, red, or hard.

Suspension Stability: VIDAZA reconstituted with non-refrigerated water for injection for subcutaneous administration may be stored for up to 1 hour at 25°C (77°F) or for up to 8 hours between 2°C and 8°C (36°F and 46°F); when reconstituted with refrigerated (2ºC - 8ºC, 36ºF - 46ºF) water for injection, it may be stored for 22 hours between 2°C and 8°C (36°F and 46°F).

2.8 Instructions for Intravenous Administration

Reconstitute the appropriate number of VIDAZA vials to achieve the desired dose. Reconstitute each vial with 10 mL sterile water for injection. Vigorously shake or roll the vial until all solids are dissolved. The resulting solution will contain azacitidine 10 mg/mL. The solution should be clear. Parenteral drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Withdraw the required amount of VIDAZA solution to deliver the desired dose and inject into a 50 -100 mL infusion bag of either 0.9% Sodium Chloride Injection or Lactated Ringer's Injection.

Intravenous Solution Incompatibility

VIDAZA is incompatible with 5% Dextrose solutions, Hespan, or solutions that contain bicarbonate. These solutions have the potential to increase the rate of degradation of VIDAZA and should therefore be avoided.

Intravenous Administration

VIDAZA solution is administered intravenously. Administer the total dose over a period of 10 - 40 minutes. The administration must be completed within 1 hour of reconstitution of the VIDAZA vial.

Solution Stability: VIDAZA reconstituted for intravenous administration may be stored at 25°C (77°F), but administration must be completed within 1 hour of reconstitution.
Otezla

Otezla

2.1 Dosage in Psoriatic Arthritis and Psoriasis

The recommended initial dosage titration of OTEZLA from Day 1 to Day 5 is shown in Table 1. Following the 5-day titration, the recommended maintenance dosage is 30 mg twice daily taken orally starting on Day 6. This titration is intended to reduce the gastrointestinal symptoms associated with initial therapy.

OTEZLA can be administered without regard to meals. Do not crush, split, or chew the tablets.
Table 1: Dosage Titration Schedule Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & thereafter AM AM PM AM PM AM PM AM PM AM PM 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg 30 mg 30 mg
2.2 Dosage Adjustment in Patients with Severe Renal Impairment

OTEZLA dosage should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance (CLcr) of less than 30 mL per minute estimated by the Cockcroft–Gault equation) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. For initial dosage titration in this group, it is recommended that OTEZLA be titrated using only the AM schedule listed in Table 1 and the PM doses be skipped.

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