Dosing & Uses
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])
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
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])
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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.
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
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)
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.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
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Leukine injection - | 250 mcg vial |  | |
| Leukine injection - | 250 mcg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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. Take the medication out of the refrigerator at least 30 minutes before you inject it to allow it to reach room temperature. 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 August 2021. 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.
Formulary
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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.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
