Pembrolizumab, lenalidomide, and avelumab all received new treatment indications in spring 2019. Here’s what you need to know about dosing, adverse events, and other nursing considerations for these and other drugs that the U.S. Food and Drug Administration (FDA) approved from April–June 2019.

Breast Cancer

  • Ado-trastuzumab emtansine (Kadcycla®) for early breast cancer
    • Approval is for those with a HER2-positive early-stage breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. 
    • Common adverse reactions are fatigue, nausea, increased transaminases, musculoskeletal pain, hemorrhage, thrombocytopenia, headache, peripheral neuropathy and arthralgia.
    • Recommended dose is 3.6 mg/kg via IV infusion every three weeks for a total of 14 cycles.
  • Alpelisib (Piqray®) for metastatic breast cancer
    • Approval is in combination with fulvestrant for men and women with HR-positive, HER2-negative, MIK3CA-mutated advanced or metastatic breast cancer. 
    • Common adverse events are hyperglycemia, elevated creatinine, diarrhea, rash, decreased lymphocyte count, nausea, and fatigue.
    • Recommended dose is 300 mg orally once daily with food. 

Head and Neck Cancer

  • Pembrolizumab (Keytruda®) for metastatic or unresectable recurrent head and neck squamous cell carcinoma
    • Approval is either as single agent or in combination with platinum and fluorouracil for patients with PD-L1-positive metastatic or unresectable head and neck squamous cell carcinoma.
    • Most common adverse events are fatigue, constipation, and rash. Patients also experienced fatigue, constipation, vomiting, mucosal inflammation, diarrhea, decreased appetite, stomatitis, and cough with pembrolizumab plus chemotherapy. Immune-related adverse events should be considered for all checkpoint inhibitors.
    • Recommended dose is 200 mg via IV over 30 minutes every three weeks.

Hematologic Cancer

  • Ivosidenib (Tivsovo®) for first-line, IDH1-positive acute myeloid leukemia
    • Approval is for adults aged 75 years or older who express the IDH1 mutation or those who have a comorbidities that preclude them from intensive induction chemotherapy.
    • Common adverse reactions are diarrhea, fatigue, edema, decreased appetite, leukocytosis, nausea, arthralgia, and abdominal pain.
    • Recommended dose is 500 mg orally once daily with or without food.
  • Venetoclax (Venclexta®) for chronic lymphocytic leukemia and small lymphocytic lymphoma
    • Common adverse events are neutropenia, thrombocytopenia, anemia, diarrhea, nausea, upper-respiratory tract infection, cough, musculoskeletal pain, fatigue, and edema.
    • Recommended dosing varies by indication, concomitant medications, and changes throughout a cycle. Refer to the package insert for dosing details.  
  • Lenalidomide (Revlimid®) for follicular and marginal zone lymphoma
    • Approval is for lenalidomide in combination with a rituximab product.
    • Common adverse events include neutropenia, fatigue, diarrhea, constipation, nausea, and cough. Black box warnings include risk of embryo-fetal toxicity, hematologic toxicity, and venous and arterial thromboembolism. 
    • Recommended dose is 20 mg orally on days 1–21 of a 28-day cycle for up to 12 cycles.
  • Polatuzumab vedotin-piiq (Polivy™) for diffuse large B-cell lymphoma
    • Approval is for adults in combination with bendamustine and a rituximab product after at least two prior therapies.
    • Common adverse events observed while on all three agents include neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, pyrexia, decreased appetite, and pneumonia. 
    • Recommended dose is 1.8 mg/kg via IV over 90 minutes every 21 days for six cycles.
  • Daratumumab (Darzalex®) for multiple myeloma when ineligible for autologous stem cell transplantation
    • Approval is in combination with lenalidomide and dexamethasone for patients unable to pursue autologous stem cell transplantation. 
    • Common adverse events are infusion reactions, diarrhea, constipation, nausea, peripheral edema, fatigue, back pain, asthenia, pyrexia, upper-respiratory tract infection, and pneumonia. 
    • Recommended dose is 16 mg/kg, but the schedule varies throughout treatment. Refer to package insert for dosing details. Pre- and postinfusion medications are needed.

Lung Cancer

  • Pembrolizumab (Keytuda®) for metastatic small cell lung cancer
    • Approval is for patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. 
    • Adverse reactions include fatigue, decreased appetite, cough, nausea, and constipation. Immune related adverse events should be considered for all checkpoint inhibitors. 
    • Recommended dose is 200 mg via IV over 30 minutes every three weeks.

Renal Cell Carcinoma

  • Pembrolizumab (Keytuda®) plus axitinib (Inlyta®) for advanced renal cell carcinoma
    • Approval is for first-line treatment of advanced renal cell carcinoma that does not have to be PD-L1 positive. 
    • Common adverse events are hepatotoxicity, diarrhea, fatigue, hypertension, hypothyroidism, decreased appetite, and palmar-plantar erythrodysesthesia. Immune-related adverse events should be considered for all checkpoint inhibitors.
    • Recommended dosing is pembrolizumab 200 mg every three weeks and axtitinib 5 mg orally twice daily.
  • Avelumab (Bavencio®) plus axitinib (Inlyta®) for renal cell carcinoma
    • Approval is for first-line treatment of advanced renal cell carcinoma that does not have to be PD-L1 positive.
    • Common adverse events are diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, and palmar-plantar erythrodysesthesia. Immune-related adverse events should be considered for all checkpoint inhibitors.
    • Recommended dosing is avelumab 800 mg every two weeks and axitinib 5 mg orally twice daily. 

With the influx of oral treatments used as single-agent therapies as well as part of multidrug regimens, refer to ONS’s variety of oral therapy resources, including patient education sheets and an oral adherence toolkit.