TRAZIMERA ONTRUZANT HERZUMA HERCEPTIN HYLECTA, Trastuzumab-Hyaluronidase-oysk HERCEPTIN, Trastuzumab OGIVRI, Trastuzumab-dkst KANJINTI Form

• Trastuzumab (Herceptin®) is a human epidermal growth factor receptor 2 (HER2)/neu receptor antagonist. • Trastuzumab-dkst (Ogivri®), trastuzumab-pkrb (Herzuma®), trastuzumab-dttb (Ontruzant®), trastuzumab-qyyp (Trazimera™), and trastuzumab-anns (Kanjinti®) are Herceptin biosimilars. • Trastuzumab-hyaluronidase-oysk (Herceptin Hylecta™) is a combination of trastuzumab and hyaluronidase, an endoglycosidase. FDA Approved Indication(s) Indications
Adjuvant breast cancer
Metastatic breast cancer For adjuvant treatment of HER2- overexpressing node positive or node negative (ER/PR negative or with one high risk feature*) breast cancer: As part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel As part of a treatment regimen with docetaxel and carboplatin
As a single agent following multi- modality anthracycline based therapy In combination with paclitaxel for first- line treatment of HER2-overexpressing metastatic breast cancer
As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease Page 1 of 16 Herceptin, Herzuma,
Ogivri, Ontruzant, Trazimera, Kanjinti X X X X X Herceptin Hylecta X X X X X

CLINICAL POLICY Trastuzumab/Biosimilars, Trastuzumab-Hyaluronidase
Herceptin, Herzuma,
Ogivri, Ontruzant, Trazimera, Kanjinti X Herceptin Hylecta – Indications
Gastric cancer In combination with cisplatin and capecitabine or 5-fluorouracil for the treatment of patients with HER2- overexpressing metastatic gastric or gastroesophageal junction (esophagogastric junction; EGJ) adenocarcinoma who have not received prior treatment for metastatic disease
Select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab. ** High-risk is defined as ER/PR positive with one of the following features: tumor size > 2 cm, age < 35 years, or tumor grade 2 or 3>
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Herceptin/biosimilars and Herceptin Hylecta are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Breast Cancer (must meet all):

1. Diagnosis of HER2-positive breast cancer or leptomeningeal metastases from HER2- positive breast cancer;

2. Prescribed by or in consultation with an oncologist;

   3. Age ≥ 18 years;
   4. If request is for Herceptin, Herzuma, or Ontruzant, member meets one of the following (a, b, or c): a. If request if for Herceptin, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated (i and ii): i. Kanjinti, Ogivri, Trazimera; ii. If member has failed Kanjinti, Ogivri, and Trazimera, then member must use Ontruzant and Herzuma; Prior authorization may be required
      b. If request is for Herzuma or Ontruzant, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated: Kanjinti, Ogivri, Trazimera; Prior authorization may be required
      c. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E); Page 2 of 16

   CLINICAL POLICY Trastuzumab/Biosimilars, Trastuzumab-Hyaluronidase

3. Request meets one of the following (a, b, c, or d): a. Herceptin, Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti: Dose does not exceed 8 mg/kg IV for adjuvant therapy or 4 mg/kg IV for treatment of metastatic disease (see Appendix D for dose rounding guidelines); b. Herceptin, Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti: Intrathecal administration for leptomeningeal metastasis; c. Herceptin Hylecta: Dose does not exceed 600 mg/10,000 units SC every 3 weeks (see Appendix D for dose rounding guidelines); d. Dose/product is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: 6 months B. Gastric, Esophageal and Esophagogastric Junction Cancer (must meet all):
4. Diagnosis of HER2-positive advanced, recurrent, or metastatic gastric, esophageal, or EGJ adenocarcinoma;
5. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Prescribed in combination with a platinum agent (i.e., either cisplatin or oxaliplatin) and either capecitabine or 5-fluorouracil;Prior authorization may be required.
6. If request is for Herceptin, Herzuma, or Ontruzant, member meets one of the following (a, b, or c): a. If request if for Herceptin, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated (i and ii): i. Kanjinti, Ogivri, Trazimera; ii. If member has failed Kanjinti, Ogivri, and Trazimera, then member must use Ontruzant and Herzuma; Prior authorization may be required
   b. If request is for Herzuma or Ontruzant, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated: Kanjinti, Ogivri, Trazimera; Prior authorization may be required
   c. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);
7. Request meets one of the following (a or b): a. Herceptin, Herzuma, Ogivri, Ontruzant, Trazimera, Kanjinti: Dose does not exceed 8 mg/kg IV (see Appendix D for dose rounding guidelines); b. Dose/product is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: 6 months C. Endometrial Carcinoma (off-label) (must meet all):

8. Diagnosis of HER2-positive endometrial carcinoma with serous histology;
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   CLINICAL POLICY Trastuzumab/Biosimilars, Trastuzumab-Hyaluronidase

9. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Disease is advanced (i.e., stage III/IV) or recurrent;
   5. Prescribed in combination with carboplatin and paclitaxel;Prior authorization may be required.
10. If request is for Herceptin, Herzuma, or Ontruzant, member meets one of the following (a, b, or c): a. If request if for Herceptin, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated (i and ii): i. Kanjinti, Ogivri, Trazimera; ii. If member has failed Kanjinti, Ogivri, and Trazimera, then member must use Ontruzant and Herzuma; Prior authorization may be required
    b. If request is for Herzuma or Ontruzant, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated: Kanjinti, Ogivri, Trazimera; Prior authorization may be required
    c. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);
11. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).Prescribed regimen must be FDA-approved or recommended by NCCN
    Approval duration: 6 months D. Colorectal Cancer (off-label) (must meet all):
12. Diagnosis of advanced or metastatic colorectal cancer and all of the following (a, b, and c): a. Disease is HER2 positive; b. Disease is wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use); c. Wild-type BRAF;

13. Prescribed by or in consultation with an oncologist;

    3. Age ≥ 18 years;
    4. If request is for Herceptin, Herzuma, or Ontruzant, member meets one of the following (a, b, or c): a. If request if for Herceptin, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated (i and ii): i. Kanjinti, Ogivri, Trazimera; ii. If member has failed Kanjinti, Ogivri, and Trazimera, then member must use Ontruzant and Herzuma; *Prior authorization may be required
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    CLINICAL POLICY Trastuzumab/Biosimilars, Trastuzumab-Hyaluronidase
    b. If request is for Herzuma or Ontruzant, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated: Kanjinti, Ogivri, Trazimera; *Prior authorization may be required
    c. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings(see Appendix E);

14. No previous use of a HER2 inhibitor therapy (e.g., trastuzumab, Kadcyla®, Tykerb®,
    Perjeta®);
15. Prescribed in combination with Perjeta (pertuzumab) or Tykerb (lapatinib);Prior authorization may be required.
16. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).Prescribed regimen must be FDA-approved or recommended by NCCN
    Approval duration: 6 months E. Salivary Gland Tumor (off-label) (must meet all):
17. Diagnosis of HER2-positive salivary gland tumor;
    
    2. Prescribed by or in consultation with an oncologist;
    3. Age ≥ 18 years;
    4. Disease is recurrent;
    5. Prescribed in one of the following manners (a, b, or c): a. Single agent; b. Combination with docetaxel; c. Combination with Perjeta; *Prior authorization may be required.
18. If request is for Herceptin, Herzuma, or Ontruzant, member meets one of the following (a, b, or c): a. If request if for Herceptin, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated (i and ii): i. Kanjinti, Ogivri, Trazimera; ii. If member has failed Kanjinti, Ogivri, and Trazimera, then member must use Ontruzant and Herzuma; Prior authorization may be required
    b. If request is for Herzuma or Ontruzant, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated: Kanjinti, Ogivri, Trazimera; Prior authorization may be required
    c. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);

19. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).Prescribed regimen must be FDA-approved or recommended by NCCN
    Approval duration: 6 months Page 5 of 16

    CLINICAL POLICY Trastuzumab/Biosimilars, Trastuzumab-Hyaluronidase
    F. Gallbladder Cancer or Cholangiocarcinoma (off-label) (must meet all):

    1. Diagnosis of HER2-positive gallbladder cancer or cholangiocarcinoma;
    2. Prescribed by or in consultation with an oncologist;
    3. Age ≥ 18 years;
    4. Disease is unresectable or metastatic;
    5. Prescribed in combination with Perjeta;
       Prior authorization may be required.
20. If request is for Herceptin, Herzuma, or Ontruzant, member meets one of the following (a, b, or c): a. If request if for Herceptin, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated (i and ii): i. Kanjinti, Ogivri, Trazimera; ii. If member has failed Kanjinti, Ogivri, and Trazimera, then member must use Ontruzant and Herzuma; Prior authorization may be required
    b. If request is for Herzuma or Ontruzant, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated: Kanjinti, Ogivri, Trazimera; Prior authorization may be required
    c. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);
21. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: 6 months G. Other diagnoses/indications (must meet all):

22. Member meets one of the following (a, b, or c): a. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E); b. If request if for Herceptin, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated (i and ii): i. Kanjinti, Ogivri, Trazimera; ii. If member has failed Kanjinti, Ogivri, and Trazimera, then member must use Ontruzant and Herzuma; Prior authorization may be required
    c. If request is for Herzuma or Ontruzant, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated: Kanjinti, Ogivri, Trazimera; Prior authorization may be required
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    CLINICAL POLICY Trastuzumab/Biosimilars, Trastuzumab-Hyaluronidase

23. Must meet one of the following (a or b): a. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (i or ii): i. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or ii. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or b. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    II. Continued Approval
    A. All Indications in Section I (must meet all):
24. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving the requested agent for a covered indication and has received this medication for at least 30 days;
    2. Member is responding positively to therapy;
    3. If request is for Herceptin, Herzuma, or Ontruzant, member meets one of the following (a, b, or c): a. If request if for Herceptin, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated (i and ii): i. Kanjinti, Ogivri, Trazimera; ii. If member has failed Kanjinti, Ogivri, and Trazimera, then member must use Ontruzant and Herzuma; Prior authorization may be required
       b. If request is for Herzuma or Ontruzant, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated: Kanjinti, Ogivri, Trazimera; Prior authorization may be required
       c. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);

25. If request is for a dose increase, request meets one of the following (a, b, or c):* a. Breast cancer (i, ii, or iii):
    i. Herceptin, Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti: New dose does not exceed 8 mg/kg IV for adjuvant therapy or 4 mg/kg IV for treatment of metastatic disease (see Appendix D for dose rounding guidelines); Page 7 of 16

    CLINICAL POLICY Trastuzumab/Biosimilars, Trastuzumab-Hyaluronidase
    ii. Herceptin, Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti: Intrathecal administration for leptomeningeal metastases; iii. Herceptin Hylecta: New dose does not exceed 600 mg/10,000 units SC every 3 weeks (see Appendix D for dose rounding guidelines); b. Gastric, esophageal, EGJ cancer: Herceptin, Herzuma, Ogivri, Ontruzant, Trazimera, Kanjinti: New dose does not exceed 8 mg/kg IV (see Appendix D for dose rounding guidelines); c. New dose/product is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: 12 months
    B. Other diagnoses/indications (must meet 1 or 2):

26. Member meets one of the following (a, b, or c): a. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E); b. If request if for Herceptin, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated (i and ii): i. Kanjinti, Ogivri, Trazimera; ii. If member has failed Kanjinti, Ogivri, and Trazimera, then member must use Ontruzant and Herzuma; Prior authorization may be required
    c. If request is for Herzuma or Ontruzant, member must use ALL of the following, unless clinically significant adverse effects are experienced or all are contraindicated: Kanjinti, Ogivri, Trazimera; Prior authorization may be required

27. Must meet one of the following (a or b): a. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (i or ii): i. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or ii. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or b. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
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    CLINICAL POLICY Trastuzumab/Biosimilars, Trastuzumab-Hyaluronidase
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration EGJ: esophagogastric junction HER2: human epidermal growth factor KRAS: Kirsten rat sarcoma 2 viral oncogene homologue NRAS: neuroblastoma RAS viral oncogene receptor 2 homologue Appendix B: Therapeutic Alternatives
    Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): none reported • Boxed warning(s):
    o Herceptin, Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti: cardiomyopathy, infusion reactions, embryo-fetal toxicity, pulmonary toxicity o Herceptin Hylecta: cardiomyopathy, embryo-fetal toxicity, pulmonary toxicity Appendix D: Dose Rounding Guidelines Weight-based Dose Range ≤ 157.49 mg 157.5 mg to 314.99 mg 315 mg to 440.99 mg 441 mg to 598.49 mg 598.5 mg to 881.99 mg 882 mg to 1,039.49 mg 1,039.5 mg to 1,322.99 mg Vial Quantity Recommendation 1 vial of 150 mg 2 vials of 150 mg 1 vial of 420 mg 1 vial of 150 mg and 1 vial 420 mg 2 vials of 420 mg 1 vial of 150 mg and 2 vials of 420 mg 3 vials of 420 mg Appendix E: States with Regulations against Redirections in Cancer State Step Therapy Prohibited? Yes Yes FL GA IA LA Yes Yes Notes For stage 4 metastatic cancer and associated conditions. For stage 4 metastatic cancer. Redirection does not refer to review of medical necessity or clinical appropriateness. For standard of care stage 4 cancer drug use, supported by peer- reviewed, evidence-based literature, and approved by FDA. For stage 4 advanced, metastatic cancer or associated conditions. Exception if “clinically equivalent therapy, contains identical active ingredient(s), and proven to have same efficacy. Page 9 of 16

    CLINICAL POLICY Trastuzumab/Biosimilars, Trastuzumab-Hyaluronidase
    State Step Therapy Prohibited? Yes NV OH OK PA TN TX Yes Yes Yes Yes Yes Notes Stage 3 and stage 4 cancer patients for a prescription drug to treat
    the cancer or any symptom thereof of the covered person Applies to Commercial and HIM requests only For stage 4 metastatic cancer and associated conditions Applies to HIM requests only For advanced metastatic cancer and associated conditions For stage 4 advanced, metastatic cancer For advanced metastatic cancer and associated conditions For stage 4 advanced, metastatic cancer and associated conditions Maximum Dose 8 mg/kg V. Dosage and Administration
    Drug Name Indication Dosing Regimen Adjuvant treatment, breast cancer
    Trastuzumab (Herceptin), Trastuzumab- dkst (Ogivri), Trastuzumab- dttb (Ontruzant), Trastuzumab- pkrb (Herzuma),
    Trastuzumab- qyyp (Trazimera), Trastuzumab- hyaluronidase -oysk (Herceptin Hylecta), Trastuzumab- anns (Kanjinti) Administer according to one of the following doses and schedules for a total of 52 weeks: Herceptin, Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti: During and following paclitaxel, docetaxel, or docetaxel/carboplatin:
    • Initial dose of 4 mg/kg as an IV infusion over 90 minutes then at 2 mg/kg as an IV infusion over 30 minutes weekly during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or 18 weeks (docetaxel/carboplatin).
    • One week following the last weekly dose of the trastuzumab product, administer trastuzumab product at 6 mg/kg as an IV infusion over 30 to 90 minutes every 3 weeks.
    Herceptin, Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti: As a single agent within 3 weeks following completion of multi-modality, anthracycline based chemotherapy regimens:
    • Initial dose: 8 mg/kg as an IV infusion over 90 minutes. • Subsequent doses: 6 mg/kg as an IV infusion over 30 to 90 minutes every 3 weeks Page 10 of 16

    CLINICAL POLICY Trastuzumab/Biosimilars, Trastuzumab-Hyaluronidase
    Drug Name Indication Dosing Regimen Metastatic treatment, breast cancer Herceptin Hylecta (subcutaneous product): As part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; as part of a treatment regimen with docetaxel and carboplatin; as a single agent following multi-modality anthracycline based therapy: 600 mg trastuzumab and 10,000 units hyaluronidase administered subcutaneously over approximately 2-5 minutes once every 3 weeks Herceptin, Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti: As a single agent, or in combination with paclitaxel, at an initial dose of 4 mg/kg as a 90-minute intravenous infusion followed by subsequent once weekly doses of 2 mg/kg as 30-minute intravenous infusions until disease progression. Herceptin Hylecta (subcutaneous product): As a single agent or in combination with paclitaxel: 600 mg trastuzumab and 10,000 units hyaluronidase administered subcutaneously over approximately 2-5 minutes once every 3 weeks. Maximum Dose 600 mg/10,000 units every 3 weeks 4 mg/kg 600 mg/10,000 units every 3 weeks Metastatic gastric cancer Herceptin, Herzuma, Ogivri, Ontruzant, Trazimera, Kanjinti: Administer at an initial dose of 8 mg/kg as a 90 minute intravenous infusion followed by subsequent doses of 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks until disease progression. 8 mg/kg
    Page 11 of 16 Trastuzumab (Herceptin), Trastuzumab- dkst (Ogivri), Trastuzumab- dttb (Ontruzant), Trastuzumab- pkrb (Herzuma), Trastuzumab- qyyp (Trazimera), Trastuzumab- hyaluronidase -oysk (Herceptin Hylecta), Trastuzumab- anns (Kanjinti) Trastuzumab (Herceptin), Trastuzumab- dkst (Ogivri), Trastuzumab- dttb (Ontruzant), Trastuzumab- qyyp (Trazimera),

    CLINICAL POLICY Trastuzumab/Biosimilars, Trastuzumab-Hyaluronidase
    Drug Name Indication Dosing Regimen Maximum Dose Trastuzumab- anns (Kanjinti) VI. Product Availability
    Drug Name Trastuzumab (Herceptin) Trastuzumab-dkst (Ogivri) Trastuzumab-pkrb (Herzuma) Trastuzumab-dttb (Ontruzant) Trastuzumab-qyyp (Trazimera) Trastuzumab-hyaluronidase- oysk (Herceptin Hylecta) Trastuzumab-anns (Kanjinti) Availability Single-dose vial: 150 mg Single-dose vial: 150 mg Multi-dose vial: 420 mg Single-dose vial: 150 mg Multi-dose vial: 420 mg Single-dose vial: 150 mg Multi-dose vial: 420 mg Single-dose vial: 150 mg Multi-dose vial: 420 mg Single-dose vial: 600 mg (trastuzumab)/10,000 units (hyaluronidase)/5 mL Single-dose vial: 150 mg Multi-dose vial: 420 mg All products are supplied as a powder for reconstitution with the exception of Herceptin Hylecta which is supplied as a solution. VII.