Atezolizumab-Hyaluronidase-SC

Atezolizumab-Hyaluronidase SC is a prescription medication used for the treatment of:

• non-small cell lung cancer (NSCLC)
• small cell lung cancer (SCLC)
• hepatocellular carcinoma (HCC)
• melanoma
• alveolar soft part sarcoma (ASPS)

Atezolizumab-Hyaluronidase SC is available under the following different brand names: Tecentriq Hybreza, atezolizumab/hyaluronidase-tqjs.

Common side effects of Atezolizumab-Hyaluronidase SC include:

• feeling tired or weak
• muscle or bone pain
• cough
• headache
• nausea
• vomiting
• constipation
• dizziness
• bleeding
• trouble sleeping
• stomach-area (abdominal) pain
• low thyroid hormone levels
• fever
• anxiety
• irregular heartbeat (arrhythmia)
• numbness, pain, tingling, or burning in the hands or feet
• hair loss
• diarrhea
• joint pain
• high blood pressure
• rash
• shortness of breath
• decreased appetite
• too much protein in the urine
• liver injury
• swelling of legs or arms
• mouth swelling (sometimes)
• sunburn or sun sensitivity

Serious side effects of Atezolizumab-Hyaluronidase SC include:

• pneumonia
• myocardial infarction

Rare side effects of Atezolizumab-Hyaluronidase SC include:

• head injury
• ischemic stroke
• pleural effusion
• pulmonary embolism
• respiratory tract infection
• sepsis
• toxic epidermal necrolysis (TEN)

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Solution for SC infusion

• 1,875 mg/30,000 units/15 mL (125 mg/2,000 units/mL single-dose vial)

Non-small cell lung cancer

Adult dosage

• Single agent
• Adjuvant therapy
  • 1,875 mg/30,000 units (15 mL) SC every 3 weeks for up to 1 year, unless disease recurrence or unacceptable toxicity occurs
• First-line treatment for metastatic disease
  • 1,875 mg/30,000 units (15 mL) SC every 3 weeks until disease progression or unacceptable toxicity
• Treatment for metastatic disease following progression
  • 1,875 mg/30,000 units (15 mL) SC every 3 weeks until disease progression or unacceptable toxicity
• Combination therapy with bevacizumab, paclitaxel, and carboplatin
  • 1,875 mg/30,000 units (15 mL) SC every 3 weeks until disease progression or unacceptable toxicity, with
• Bevacizumab, paclitaxel, and carboplatin every 21 days for 4-6 cycles
  • Administer before chemotherapy and bevacizumab when given on the same day
• Combination therapy with paclitaxel protein-bound and carboplatin
  • 1,875 mg/30,000 units (15 mL) SC every 3 weeks until disease progression or unacceptable toxicity, with
  • Paclitaxel protein-bound and carboplatin every 21 days for 4-6 cycles
  • Administer before chemotherapy when given on the same day

Small cell lung cancer

Adult dosage

• 1,875 mg/30,000 units (15 mL) SC every 3 weeks until disease progression or unacceptable toxicity, with
• Carboplatin and etoposide every 21 days for up to 4 cycles
• Administer before chemotherapy when given on the same day

Hepatocellular carcinoma

Adult dosage

• 1,875 mg/30,000 units (15 mL) SC every 3 weeks, with
• Bevacizumab 15 mg/kg IV every 3 weeks
• Continue until disease progression or unacceptable toxicity
• Administer before bevacizumab when given on the same day

Melanoma

Adult dosage

• Before initiation
  • Administer one 28-day cycle of cobimetinib and vemurafenib
  • Cobimetinib 60 mg orally once a day on Days 1-21, plus
  • Vemurafenib 960 mg orally two times a day on Days 1-21, then 720 mg orally two times a day on Days 22-28
• Subsequent 28-day cycles
  • 1,875 mg/30,000 units (15 mL) SC every 3 weeks, with
  • Cobimetinib 60 mg orally once a day on Days 1-21, plus
  • Vemurafenib 720 mg orally two times a day on Days 1-28
  • Continue until disease progression or unacceptable toxicity

Alveolar soft part sarcoma

Adult dosage

• 1,875 mg/30,000 units (15 mL) SC every 3 weeks until disease progression or unacceptable toxicity

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Atezolizumab-Hyaluronidase SC has no noted severe interactions with any other drugs
• Atezolizumab-Hyaluronidase SC has no noted serious interactions with any other drugs
• Atezolizumab-Hyaluronidase SC has no noted moderate interactions with any other drugs
• Atezolizumab-Hyaluronidase SC has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to hyaluronidase or its excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Atezolizumab-Hyaluronidase SC?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Atezolizumab-Hyaluronidase SC?”

Cautions

• Immune-mediated adverse reactions
  • Severe and fatal immune-mediated reactions reported
  • Can occur in any organ system or tissue at any time after starting therapy, including after therapy discontinuation
  • Monitor for symptoms and signs of clinical manifestations of underlying immune-mediated adverse reactions
  • For suspected reactions, initiate appropriate workup to exclude alternative etiologies (e.g., infection)
  • Institute medical management promptly; consult specialists as appropriate
  • Withhold or permanently discontinue depending on the severity
  • Administer systemic corticosteroids (e.g., 1-2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 and below, then taper corticosteroids over at least 1 month
  • Other systemic immunosuppressants may be required if reactions are not controlled with corticosteroids
• Pneumonitis
  • Immune-mediated pneumonitis can occur
  • Incidence of pneumonitis is higher following prior thoracic radiation
• Colitis
  • Immune-mediated colitis may present with diarrhea, abdominal pain, and lower GI bleeding
  • Cytomegalovirus (CMV) infection/reactivation reported with corticosteroid-refractory immune-mediated colitis
  • For corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies
• Hepatitis
  • Immune-mediated hepatitis can occur
  • Evaluate liver enzymes before initiation and periodically during therapy
• Endocrinopathies
  • Immune-mediated adrenal insufficiency, hypophysitis, thyroiditis, hyperthyroidism, and hypothyroidism reported
  • Initiate symptomatic treatment (e.g., hormone replacement, anti-thyroid agent) as clinically indicated
  • Evaluate thyroid function before initiation and periodically during therapy
• Type 1 diabetes mellitus
  • Immune-mediated type 1 diabetes mellitus may occur; may present with diabetic ketoacidosis
  • Monitor for hyperglycemia or other signs and symptoms of diabetes
  • Initiate treatment with insulin as clinically indicated
• Nephritis
  • Immune-mediated nephritis with renal dysfunction can occur
  • Evaluate renal function before initiation and periodically during therapy
• Dermatologic reactions
  • Immune-mediated rash or dermatitis can occur; fatal cases of TEN reported
  • Other exfoliative dermatitis reactions may include Stevens-Johnson syndrome (SJS) and drug rash with eosinophilia and systemic symptoms (DRESS)
  • Treat mild-to-moderate nonexfoliative rashes with topical emollients and/or topical corticosteroids
• Infusion-related reactions (IRR)
  • Severe or life-threatening IRR may occur
  • Monitor for signs and symptoms of IRR
  • Withhold, slow the rate, or permanently discontinue based on severity
  • For Grade 1 or 2 IRR, consider giving premedications with subsequent doses
• Allogeneic hematopoietic stem cell transplantation (HSCT) complications
  • Fatal and other serious allogeneic HSCT complications can occur in patients who receive a PD-1/PD-L1 blocking antibody before or after HSCT
  • Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause)
  • Complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT
  • Monitor for evidence of transplant-related complications and intervene promptly
  • Consider the benefits versus risks of treatment with a PD-1/PD-L1 blocking antibody before or after allogeneic HSCT
• Embryo-fetal toxicity
  • Fetal harm may occur if used during pregnancy
  • Advise patients of the reproductive potential of possible risk to the fetus
  • Effective contraception is recommended during and after therapy

Pregnancy and Lactation

• May cause fetal harm when administered during pregnancy, based on its mechanism of action
• No available data on use in pregnant women
• Perform pregnancy testing before starting therapy
• Contraception
  • Advise females of reproductive potential to use effective contraception during treatment and for 5 months after the last dose
  • Infertility
  • Based on animal studies, this drug may impair fertility in females of reproductive potential while receiving treatment
• Lactation
  • No data are available on the presence of the drug in human milk, their effects on breastfed children, or milk production
  • Maternal IgG is known to be present in human milk; effects of local GI exposure and limited systemic exposure in breastfed children are unknown
  • Because of the potential for adverse reactions in breastfed children, advise patients to avoid breastfeeding during treatment and for 5 months after the last dose