sargramostim (Rx)

Brand and Other Names:gmcsf, Leukine
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injectable solution

  • 500mcg/mL

injection, lyophilized powder for reconstitution

  • 250mcg/vial

Acute Myeloid Leukemia Following Induction Chemotherapy

Indicated to shorten time to neutrophil recovery and to reduce incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients ≥55 years with acute myeloid leukemia (AML)

250 mcg/m²/day IV over a 4-hr period starting ~ Day 11 or 4 days following completion of induction chemotherapy, if the day 10 bone marrow is hypoplastic with <5% blasts  

If a second cycle of induction chemotherapy is necessary, administer ~4 days after completion of chemotherapy if the bone marrow is hypoplastic with <5% blasts

Continue until an absolute neutrophil count (ANC) >1500 cells/mm³ for 3 consecutive days (not to exceed 42 days); do not administer sargramostim within 24 hr preceding or following receipt of chemotherapy or radiotherapy

Autologous Peripheral Blood Progenitor Cell Mobilization and Collection

Indicated in adults with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis

250 mcg/m²/day IV over 24 hr or SC qDay; continue at the same dose through PBPC collection  

Optimal schedule for PBPC collection not established

In clinical studies, collection of PBPC was usually begun after 5 days of sargramostim and performed daily until protocol specified targets were achieved

Autologous Peripheral Blood Progenitor Cell and Bone Marrow Transplantation

Indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation in adults with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's lymphoma (HL)

Autologous peripheral blood progenitor cell transplantation

  • 250 mcg/m²/day IV over 24 hr or SC qDay beginning immediately following infusion of progenitor cells and continuing until an ANC >1500 cells/mm³ for 3 consecutive days is attained  
  • Do not administer sargramostim within 24 hr preceding or following receipt of chemotherapy or radiotherapy

Autologous bone marrow transplantation

  • 250 mcg/m²/day IV over a 2-hr period beginning 2-4 hr after bone marrow infusion, and not <24 hr after the last dose of chemotherapy or radiotherapy  
  • Do not administer sargramostim until post marrow infusion ANC is <500 cells/mm³
  • Continue until an ANC >1500 cells/mm³ for 3 consecutive days is attained
  • Do not administer sargramostim within 24 hr preceding or following receipt of chemotherapy or radiotherapy

Allogeneic Bone Marrow Transplantation

Indicated for the acceleration of myeloid reconstitution in adults undergoing allogeneic bone marrow transplantation from HLA-matched related donors

250 mcg/m²/day IV over a 2-hr period beginning 2-4 hr after bone marrow infusion, and not <24 hr after the last dose of chemotherapy or radiotherapy  

Do not administer sargramostim until post marrow infusion ANC is <500 cells/mm³

Continue until an ANC >1500 cells/mm³ for 3 consecutive days is attained

Do not administer sargramostim within 24 hr preceding or following receipt of chemotherapy or radiotherapy

Treatment of Delayed Neutrophil Recovery or Graft Failure

Indicated for the treatment of adults undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed

250 mcg/m²/day IV over a 2hr for 14 days  

If neutrophil recovery not occurred, dose can be repeated after 7 days off; if neutrophil recovery still not occurred, a third course of 500 mcg/m²/day for 14 days may be tried after another 7 days off therapy

If still no improvement, it is unlikely further dose escalation will be beneficial

Acute Radiation Syndrome

Indicated to increase survival in adults acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS])

7 mcg/kg SC qDay  

Administer as soon as possible after suspected or confirmed exposure to radiation doses >2 gray (Gy)

Estimate a patient’s absorbed radiation dose (ie, level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings such as time to onset of vomiting or lymphocyte depletion kinetics

H-ARS monitoring and dose duration

  • Obtain baseline CBC with differential and then serial CBCs ~every 3 days until the ANC remains >1000/mm³ for 3 consecutive CBCs
  • Do not delay administration if a CBC is not readily available
  • Continue administration until the ANC remains >1000/mm³ for 3 consecutive CBCs or exceeds 10,000/mm³ after a radiation-induced nadir

MDS (Off-label)

15-500 mcg/m² IV infusion qDay over 1-12 hr OR 30-500 mcg/m² continuous infusion over 24 hr  

Aplastic Anemia (Off-label)

15-480 mcg/m² IV infusion qDay over 1-12 hr OR 120-500 mcg/m² continuous infusion over 24 hr  

Dosage Modifications

Obtain a CBC with differential twice a week during therapy and modify dose

Neutrophil recovery following induction chemotherapy for AML

  • Leukemic regrowth: Discontinue sargramostim immediately
  • Grade 3 or 4 adverse reactions: Reduce dose of sargramostim by 50% or interrupt dosing until the reaction abates
  • ANC >20,000 cells/mm³: Interrupt sargramostim treatment or reduce dose by 50%

Allogeneic bone marrow transplantation or treatment of delayed neutrophil recovery or graft failure

  • Disease progression or blast cell appearance: Discontinue sargramostim immediately
  • Grade 3 or 4 adverse reactions: Reduce dose of sargramostim by 50% or temporarily discontinue until reaction abates
  • WBC >50,000 cells/mm³ or ANC >20,000 cells/mm³ : Interrupt sargramostim treatment or reduce dose by 50%

Orphan Designations

Cystic fibrosis

  • Orphan sponsor: DrugRecure Aps; Cobis Building, 2200 Copenhagen N; Denmark

Pulmonary alveolar proteinosis (PAP)

  • Orphan sponsor: Partner Therapeutics, Inc; 19 Muzzey Street; Lexington, Massachusetts 02421

Melanoma stage IIb-IV

  • Orphan sponsor: Partner Therapeutics, Inc; 19 Muzzey Street; Lexington, Massachusetts 02421

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 250mcg/vial

Autologous Peripheral Blood Progenitor Cell and Bone Marrow Transplantation

Indicated for the acceleration of myeloid reconstitution following autologous PBPC or bone marrow transplantation in pediatric patients ≥2 years with NHL, ALL, and HL

Autologous peripheral blood progenitor cell transplantation

  • ≤2 years;: Safety and efficacy not established
  • >2 years
    • 250 mcg/m²/day IV over 24 hr or SC qDay beginning immediately following infusion of progenitor cells and continuing until an ANC >1500 cells/mm³ for 3 consecutive days is attained  
    • Do not administer sargramostim within 24 hr preceding or following receipt of chemotherapy or radiotherapy

Autologous bone marrow transplantation

  • ≤2 years;: Safety and efficacy not established
  • >2 years
    • 250 mcg/m²/day IV over a 2-hr period beginning 2-4 hr after bone marrow infusion, and not <24 hr after the last dose of chemotherapy or radiotherapy  
    • Do not administer sargramostim within 24 hr preceding or following receipt of chemotherapy or radiotherapy
    • Continue until an ANC >1500 cells/mm³ for 3 consecutive days is attained

Acute Radiation Syndrome

Indicated to increase survival in children and adolescents acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS])

<15 kg: 12 mcg/kg SC qDay  

15-40 kg:10 mcg/kg SC qDay  

>40 kg:7 mcg/kg SC qDay  

Administer as soon as possible after suspected or confirmed exposure to radiation doses >2 gray (Gy)

Estimate a patient’s absorbed radiation dose (ie, level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings such as time to onset of vomiting or lymphocyte depletion kinetics

H-ARS monitoring and dose duration

  • Obtain baseline CBC with differential and then serial CBCs ~every 3 days until the ANC remains >1000/mm³ for 3 consecutive CBCs
  • Do not delay administration if a CBC is not readily available
  • Continue administration until the ANC remains >1000/mm³ for 3 consecutive CBCs or exceeds 10,000/mm³ after a radiation-induced nadir

Clinical studies did not include sufficient numbers of subjects aged ≥65 to determine whether they respond differently from younger subjects

Other reported clinical experience has not identified differences in responses between the elderly and younger patients

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Interactions

Interaction Checker

and sargramostim

No Results

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (1)

                • ifosfamide

                  ifosfamide will decrease the level or effect of sargramostim by Other (see comment). Modify Therapy/Monitor Closely. Do not administer simultaneously with or within 24 hours preceding/following cytotoxic chemotherapy or radiotherapy (due to the sensitivity of rapidly dividing hematopoietic progenitor cells).

                Minor (10)

                • budesonide

                  budesonide increases effects of sargramostim by pharmacodynamic synergism. Minor/Significance Unknown.

                • cortisone

                  cortisone increases effects of sargramostim by pharmacodynamic synergism. Minor/Significance Unknown.

                • dexamethasone

                  dexamethasone increases effects of sargramostim by pharmacodynamic synergism. Minor/Significance Unknown.

                • fludrocortisone

                  fludrocortisone increases effects of sargramostim by pharmacodynamic synergism. Minor/Significance Unknown.

                • hydrocortisone

                  hydrocortisone increases effects of sargramostim by pharmacodynamic synergism. Minor/Significance Unknown.

                • lithium

                  lithium increases effects of sargramostim by pharmacodynamic synergism. Minor/Significance Unknown.

                • methylprednisolone

                  methylprednisolone increases effects of sargramostim by pharmacodynamic synergism. Minor/Significance Unknown.

                • prednisolone

                  prednisolone increases effects of sargramostim by pharmacodynamic synergism. Minor/Significance Unknown.

                • prednisone

                  prednisone increases effects of sargramostim by pharmacodynamic synergism. Minor/Significance Unknown.

                • triamcinolone acetonide injectable suspension

                  triamcinolone acetonide injectable suspension increases effects of sargramostim by pharmacodynamic synergism. Minor/Significance Unknown.

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                Adverse Effects

                >10%

                Autologous BMT

                • Abdominal pain (89%)
                • Diarrhea (89%)
                • Asthenia (66%)
                • Malaise (57%)
                • Rash (44%)
                • Chest pain (11%)
                • Peripheral edema (11%)

                Acute myelogenous leukemia

                • Fever (81%)
                • Skin reaction (77%)
                • Metabolic disease (58%)
                • Nausea (58%)
                • Vomiting (46%)
                • Weight loss (37%)

                Diarrhea (allogenic BMT 81%)

                Nausea (allogenic BMT 70%)

                Vomiting (allogenic BMT 70%)

                Abdominal pain (allogenic BMT 38%)

                Hyperbilirubinemia (allogenic BMT 30%)

                Rigor (allogenic BMT 25%)

                Cardiac dysrhythmia (BMT graft failure 25%)

                Pericardial effusion (BMT graft failure 25%)

                Pruritis (allogenic BMT 23%)

                Increase serum BUN (allogenic BMT 23%)

                Pharyngitis (allogenic BMT 23%)

                Bone pain (allogenic BMT 21%)

                Myalgia (BMT graft failure 18%)

                Hypercholesterolemia (allogenic BMT 17%)

                Hypomagnesemia (allogenic BMT 15%)

                Chest pain (allogenic BMT 15%)

                Hematemesis (allogenic BMT 13%)

                GI hemorrhage (allogenic BMT 11%)

                Intraocular hemorrhage (allogenic BMT 11%)

                Dysphagia (allogenic BMT 11%)

                Arthralgia (allogenic BMT 11%)

                1-10%

                Cardiac dysrhythmia (autologous BMT 4%)

                Pericardial effusion (autologous BMT 4%)

                <1%

                Capillary leak syndrome

                Frequency Not Defined

                Anorexia

                Fever

                Malaise

                Cerebral hemorrhage

                Stomatitis

                Elevated BUN and cholesterol

                Renal failure

                Sepsis

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                Warnings

                Contraindications

                History of serious allergic reactions (eg, anaphylaxis to human GCSFs [such as sargramostim], yeast-derived products, or any component of the product)

                >10% leukemic myeloid blasts in bone marrow or peripheral blood

                Do not administer within 24 hr preceding or following chemotherapy or radiotherapy

                Cautions

                Caution in fluid retention, pulmonary infiltrates, CHF, lung disease, cardiac disease, hypoxia, hepatic/renal impairment; conditions may worsen

                Solution should NOT be administered to neonates due to presence of benzyl alcohol in the formulation ant its association with "gasping syndrome"

                Discontinue immediately if blast cells appear or disease progression occurs

                Reformulated liquid devoid of sodium EDTA now available

                Treatment may induce neutralizing anti-drug antibodies; incidence of anti-sargramostim neutralizing antibodies may be related to duration of exposure

                A first dose effect characterized by respiratory distress, hypoxia, flushing, hypotension , syncope, and/or tachycardia, may occur with the first dose of the cycle and resolve with appropriate symptomatic treatment; symptoms do not usually occur with subsequent doses within that cycle

                Edema, capillary leak syndrome, pleural and/or pericardial effusion; fluid retention shown to be reversible with dosage reduction or discontinuation with or without concomitant use of diuretics

                If there is a rapid increase in blood counts (ANC ≥20,000/mm³, WBC >50,000/mm³, platelets >500,000/mm³), decrease dose by 50% or discontinue therapy; excessive blood counts should fall to normal within 3-7 days after discontinuation of therapy; monitor with differential twice weekly during treatment

                Sequestration of granulocytes in pulmonary circulation and dyspnea reported; monitor respiratory symptoms during and following IV infusion; decrease infusion rate by 50% if dyspnea occurs; discontinue infusion if dyspnea persists despite reduction in rate of administration; subsequent doses may be administered at standard rate with careful monitoring

                Supraventricular arrhythmia reported in uncontrolled studies during administration, particularly in patients with a previous history of cardiac arrhythmia

                Serious hypersensitivity reactions, including anaphylactic reactions reported (see Contraindications)

                May cause infusion-related reactions

                Owing to the possibility of tumor growth potentiation, exercise caution when using this drug in any malignancy with myeloid characteristic

                Avoid concomitant use of sargramostim and products that induce myeloproliferation (eg, lithium, corticosteroids)

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                Pregnancy & Lactation

                Pregnancy

                Limited available data on use in pregnant women are insufficient to inform the drug-associated risk of adverse developmental outcomes

                Based on animal studies, sargramostim may cause embryofetal harm; administration to pregnant rabbits during organogenesis resulted in adverse developmental outcomes including increased spontaneous abortion at systemic exposures ≥1.3 times the human exposure expected at the recommended human dose

                Advise pregnant women of the potential risk to a fetus

                Lactation

                No information regarding the presence of drug in human milk, the effects on the breastfed child, or the effects on milk production

                Administration of sargramostim to rabbits during lactation resulted in reduction in postnatal offspring survival; advise a lactating woman not to breastfeed during treatment and for at least 2 weeks after last dose

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Recombinant granulocyte macrophage colony stimulating factor; acts on hematopoietic cells to stimulate proliferation & differentiation particularly into neutrophils, monocytes/macrophages & myeloid-derived dendritic cells & some end cell function activity

                Absorption

                Peak plasma concentration: 16.7 ng/mL (IV); 3.03 ng/mL (SC)

                AUC: 32.9 ng·hr /mL (IV); 21.3 ng·hr/mL (SC)

                Bioavailability: 75% (SC)

                Distribution

                Vd: 96.8 L (IV)

                Excretion

                Half-life elimination: 3.84 h (IV); 1.4 h (SC)

                Clearance: 17.2 L/h (IV); 23 L/h

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                Administration

                IV Incompatibilities

                Y-site: acyclovir, amphotericin B(?), ampicillin, ampicillin/sulbactam, amsacrine(?), cefoperazone, ceftazidime(?), chlorpromazine, ganciclovir, haloperidol, hydrocortisone sodium phosphate, hydrocortisone sodium succinate, hydromorphone, hydroxyzine, imipenem/cilastatin, lorazepam, methylprednisolone sodium succinate, mitomycin, morphine, nalbuphine, ondansetron, piperacillin, sodium bicarbonate, tobramycin, vancomycin in albumin-containing solns

                IV Compatibilities

                Y-site (partial list): bleomycin, carboplatin, carmustine, cisplatin, cyclophosphamide, cytarabine, dacarbazine, dactinomycin, diphenhydramine, dopamine, doxorubicin, doxycycline, fentanyl, fluorouracil, furosemide, heparin, idarubicin, ifosfamide, MgSO4, mechlorethamine, meperidine, methotrexate, metronidazole, teniposide, vancomycin in albumin-free solns, vinblastine

                Preparation

                Lyophilized powder

                • Reconstitute with 1 mL of diluent; do not mix contents of vials reconstituted with different diluents together
                • Reconstitute with either sterile water for injection (without preservative) or bacteriostatic water for injection
                • Use reconstituted sargramostim vials within 6 hr following dilution for IV infusion; do not re-enter or reuse the vial
                • Discard any unused portions

                Solution

                • For SC injection: Administer without further dilution
                • For IV infusion
                  • Dilute in 0.9% NaCl Final concentration of diluted sargramostim <10 mcg/mL, add albumin (Human) at a final concentration of 0.1% to 0.9% NaCl prior to addition of sargramostim to prevent adsorption to the components of the drug delivery system
                  • To obtain a final concentration of 0.1% albumin (Human), add 1 mg Albumin (Human) per 1 mL 0.9% NaCl (eg, use 1 mL 5% albumin [Human] in 50 mL 0.9% NaCl)

                SC Administration

                Do not administer simultaneously with or within 24 hr preceding cytotoxic chemotherapy or radiotherapy or within 24 hr following chemotherapy

                Sargramostim injection is formulated as a sterile solution preserved with 1.1% benzyl alcohol; injection should appear clear, colorless single-dose solution

                Use only sargramostim for injection (lyophilized powder) reconstituted with sterile water for injection without preservatives when administering to neonates or infants to avoid benzyl alcohol exposure

                IV Administration

                Do NOT use an inline membrane filter for IV infusion In absence of compatibility and stability information, do not add other medication to infusion solutions containing sargramostim

                Use only 0.9% NaCl to prepare IV infusion solutions

                Visually inspect for particulate matter and discoloration prior to administration; if particulate matter is present or the solution is discolored, vial should not be used

                Usual infusion over 2-4 hr, although longer, shorter or continuous infusions have been done

                Storage

                Unused vials

                • Refrigerate at 2-8°C (36-46°F) in the original carton to protect from light; do not freeze or shake; do not use beyond the expiration date printed on the vial

                Diluted solutions or reconstituted vials

                • Refrigerate at 2-8°C (36-46°F) for up to 20 days once the vial has been entered; discard any remaining solution after 20 days; do not freeze
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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Leukine injection
                -
                250 mcg vial
                Leukine injection
                -
                250 mcg vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                sargramostim injection

                SARGRAMOSTIM - INJECTION

                (SAR-gra-MOE-stim)

                COMMON BRAND NAME(S): Leukine

                USES: Sargramostim is a man-made version of a certain natural substance made in your body. It is used to help your body make more white blood cells. White blood cells are important to help you fight off infections. Sargramostim is given to people whose ability to make white blood cells is reduced (for instance, due to chemotherapy or exposure to large amounts of radiation). It is also used in certain treatment procedures (such as bone marrow/stem cell transplant).

                HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using sargramostim and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection under the skin or into a vein as directed by your doctor, usually once a day. The dosage is based on your medical condition, body size, lab tests, and response to treatment.If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Do not shake the medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.If you are injecting this drug under the skin, first clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject sargramostim into skin that is bruised, tender, red, hard, or that has scars or stretch marks.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.This medication may cause a reaction after the first dose of each treatment period. Tell your doctor or nurse right away if you have any signs of a serious reaction, including: flushing, shortness of breath, dizziness, fainting, or fast heartbeat.Learn how to store and discard medical supplies safely.If you are receiving cancer chemotherapy or radiation treatment, you should not use this medication within 24 hours before or 24 hours after chemotherapy or radiation treatment. Ask your doctor for specific directions about when to use this medication.

                SIDE EFFECTS: Aching or pain in the bones and muscles or headache may occur. Taking a non-aspirin pain reliever such as acetaminophen may help relieve pain. Ask your doctor or pharmacist for more details. Redness, swelling, itching, or bruising at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: fast/irregular heartbeat, chest pain, sudden weight gain, swelling ankles/feet/hands, shortness of breath, black/bloody stools, stomach/abdominal pain, vomit that is bloody or looks like coffee grounds, vision problems.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before using sargramostim, tell your doctor or pharmacist if you are allergic to it; or to yeast; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung disease, heart problems (such as heart failure, irregular heartbeat), liver disease, kidney disease, swelling (edema).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Lab and/or medical tests (such as complete blood count, kidney/liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

                MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

                STORAGE: Store in the refrigerator. Keep the medication in the original package to protect from light. Do not freeze or shake. After mixing, use within time period indicated in the product instructions or consult your pharmacist. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                Information last revised May 2022. Copyright(c) 2022 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
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                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.