Opdivo Qvantig Dosage

Generic name: NIVOLUMAB 120mg in 1mL, HYALURONIDASE (HUMAN RECOMBINANT) 2000U in 1mL
Dosage form: subcutaneous injection
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)

Medically reviewed by Drugs.com. Last updated on Dec 27, 2024.

Important Dosage and Administration Information

OPDIVO QVANTIG has different dosage and administration instructions than intravenously administered nivolumab products.

OPDIVO QVANTIG is for subcutaneous use only in the abdomen or thigh. Do not administer intravenously.

OPDIVO QVANTIG is to be administered by a healthcare professional only.

Adult patients currently receiving intravenous nivolumab as a single agent, or in combination with chemotherapy or cabozantinib, may switch to subcutaneous OPDIVO QVANTIG at their next scheduled dose.

Recommended Dosage

The recommended dosages of OPDIVO QVANTIG as monotherapy agent are presented in Table 1.

Table 1: Recommended Dosages for OPDIVO QVANTIG as Monotherapy
† Dosing recommendations for both monotherapy or following intravenous nivolumab and ipilimumab combination therapy. * Administer over 3-5 minutes.
Indication	Recommended OPDIVO QVANTIG Dosage	Duration of Therapy
Advanced renal cell carcinoma†	600 mg nivolumab and 10,000 units hyaluronidase* every 2 weeks or 1,200 mg nivolumab and 20,000 units hyaluronidase* every 4 weeks	Until disease progression or unacceptable toxicity
Unresectable or metastatic melanoma†
Metastatic non-small cell lung cancer
Squamous cell carcinoma of the head and neck
Locally advanced or metastatic urothelial carcinoma
Microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer†
Hepatocellular carcinoma†
Esophageal squamous cell carcinoma
Adjuvant treatment of melanoma	600 mg nivolumab and 10,000 units hyaluronidase* every 2 weeks or 1,200 mg nivolumab and 20,000 units hyaluronidase* every 4 weeks	Until disease recurrence or unacceptable toxicity for up to 1 year
Adjuvant treatment of urothelial carcinoma
Adjuvant treatment of resected esophageal or gastroesophageal junction cancer

The recommended dosages of OPDIVO QVANTIG in combination with other therapeutic agents are presented in Table 2. Refer to the respective Prescribing Information for each therapeutic agent administered in combination with OPDIVO QVANTIG for the recommended dosage information, as appropriate.

Table 2: Recommended Dosages for OPDIVO QVANTIG in Combination with Other Therapeutic Agents
* Administer over 3-5 minutes.
Indication	Recommended OPDIVO QVANTIG Dosage	Duration of Therapy
Advanced renal cell carcinoma	600 mg nivolumab and 10,000 units hyaluronidase* every 2 weeks or 1,200 mg nivolumab and 20,000 units hyaluronidase* every 4 weeks Administer OPDIVO QVANTIG in combination with cabozantinib 40 mg orally once daily without food	OPDIVO QVANTIG: Until disease progression, unacceptable toxicity, or up to 2 years Cabozantinib: Until disease progression or unacceptable toxicity
Neoadjuvant treatment of resectable non-small cell lung cancer	900 mg nivolumab and 15,000 units hyaluronidase* with platinum-doublet chemotherapy on the same day every 3 weeks	In combination with platinum-doublet chemotherapy for 3 cycles
Neoadjuvant and adjuvant treatment of resectable non-small cell lung cancer	Neoadjuvant: 900 mg nivolumab and 15,000 units hyaluronidase* with platinum-doublet chemotherapy on the same day every 3 weeks	Neoadjuvant: in combination with platinum-doublet chemotherapy until disease progression or unacceptable toxicity, for up to 4 cycles
	Adjuvant: 1,200 mg nivolumab and 20,000 units hyaluronidase* every 4 weeks	Adjuvant: following neoadjuvant therapy and surgery, administer as a single agent until disease progression, recurrence, or unacceptable toxicity, for up to 13 cycles (up to 1 year)
First-line unresectable or metastatic urothelial carcinoma	900 mg nivolumab and 15,000 units hyaluronidase* every 3 weeks Administer OPDIVO QVANTIG in combination with cisplatin and gemcitabine on the same day every 3 weeks	In combination with cisplatin and gemcitabine for up to 6 cycles
First-line unresectable or metastatic urothelial carcinoma	600 mg nivolumab and 10,000 units hyaluronidase* every 2 weeks or 1,200 mg nivolumab and 20,000 units hyaluronidase* every 4 weeks	After completing up to 6 cycles of combination therapy, administer as single agent until disease progression, unacceptable toxicity, or up to 2 years from first dose
Esophageal squamous cell carcinoma	600 mg nivolumab and 10,000 units hyaluronidase* every 2 weeks or 1,200 mg nivolumab and 20,000 units hyaluronidase* every 4 weeks Administer OPDIVO QVANTIG in combination with fluoropyrimidine- and platinum-containing chemotherapy	Until disease progression, unacceptable toxicity, or up to 2 years
Esophageal squamous cell carcinoma		Chemotherapy: Until disease progression or unacceptable toxicity
Gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma	600 mg nivolumab and 10,000 units hyaluronidase* with fluoropyrimidine- and platinum-containing chemotherapy every 2 weeks or 900 mg nivolumab and 15,000 units hyaluronidase* with fluoropyrimidine- and platinum-containing chemotherapy every 3 weeks	OPDIVO QVANTIG: Until disease progression, unacceptable toxicity, or up to 2 years Chemotherapy: Until disease progression or unacceptable toxicity

Dose Modifications

No dose reduction for OPDIVO QVANTIG is recommended. In general, withhold OPDIVO QVANTIG for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue OPDIVO QVANTIG for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating steroids.

Dosage modifications for OPDIVO QVANTIG or OPDIVO QVANTIG in combination with other anti-cancer agents for adverse reactions that require management different from these general guidelines are summarized in Table 3 and Table 4.

Table 3: Recommended Dosage Modifications for Adverse Reactions
a Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of last dose or inability to reduce prednisone to 10 mg per day (or equivalent) or less within 12 weeks of initiating steroids. b If AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue OPDIVO QVANTIG based on recommendations for hepatitis with no liver involvement. c Depending on clinical severity, consider withholding for Grade 2 endocrinopathy until symptom improvement with hormone replacement. Resume once acute symptoms have resolved. ALT = alanine aminotransferase, AST = aspartate aminotransferase, DRESS = Drug Rash with Eosinophilia and Systemic Symptoms, SJS = Stevens-Johnson Syndrome, TEN = toxic epidermal necrolysis, ULN = upper limit of normal
Adverse Reaction	Severity	Dosage Modification
Immune-Mediated Adverse Reactions
Pneumonitis	Grade 2	Withholda
Pneumonitis	Grade 3 or 4	Permanently discontinue
Colitis For colitis in patients treated with combination therapy with ipilimumab, see Table 4.	Grade 2 or 3	Withholda
	Grade 4	Permanently discontinue
Hepatitis with no tumor involvement of the liver For liver enzyme elevations in patients treated with combination therapy with cabozantinib, see Table 4.	AST/ALT increases to >3 and ≤8 times ULN or Total bilirubin increases to >1.5 and ≤3 times ULN.	Withholda
	AST or ALT increases to >8 times ULN or Total bilirubin increases to >3 times ULN.	Permanently discontinue
Hepatitis with tumor involvement of the liverb	Baseline AST/ALT is >1 and ≤3 times ULN and increases to >5 and ≤10 times ULN or Baseline AST/ALT is >3 and ≤5 times ULN and increases to >8 and ≤10 times ULN.	Withholda
Hepatitis with tumor involvement of the liverb	AST/ALT increases to >10 times ULN or Total bilirubin increases to >3 times ULN.	Permanently discontinue
Endocrinopathiesc	Grade 3 or 4	Withhold until clinically stable or permanently discontinue depending on severity
Nephritis with Renal Dysfunction	Grade 2 or 3 increased blood creatinine	Withholda
Nephritis with Renal Dysfunction	Grade 4 increased blood creatinine	Permanently discontinue
Exfoliative Dermatologic Conditions	Suspected SJS, TEN, or DRESS	Withhold
Exfoliative Dermatologic Conditions	Confirmed SJS, TEN, or DRESS	Permanently discontinue
Myocarditis	Grades 2, 3, or 4	Permanently discontinue
Neurological Toxicities	Grade 2	Withholda
Neurological Toxicities	Grade 3 or 4	Permanently discontinue

Table 4: Recommended Dosage Modifications for Adverse Reactions in Patients Treated with Combination Therapy
a Consider corticosteroid therapy for hepatic adverse reactions if OPDIVO QVANTIG is withheld or discontinued when administered in combination with cabozantinib. b After recovery, rechallenge with one or both of OPDIVO QVANTIG and cabozantinib may be considered. If rechallenging with cabozantinib with or without OPDIVO QVANTIG, refer to cabozantinib Prescribing Information.
Treatment	Adverse Reaction	Severity	Dosage Modification
OPDIVO QVANTIG in combination with cabozantinib	Liver enzyme elevations	ALT or AST >3 times ULN but ≤10 times ULN with concurrent total bilirubin <2 times ULN	Withholda both OPDIVO QVANTIG and cabozantinib until adverse reactions recoverb to Grades 0-1
OPDIVO QVANTIG in combination with cabozantinib	Liver enzyme elevations	ALT or AST >10 times ULN or >3 times ULN with concurrent total bilirubin ≥2 times ULN	Permanently discontinuea both OPDIVO QVANTIG and cabozantinib

Preparation and Administration

To prevent medication errors, check the vial labels to ensure that the drug being prepared and administered is OPDIVO QVANTIG for subcutaneous use and NOT intravenous nivolumab. Do NOT administer OPDIVO QVANTIG intravenously. OPDIVO QVANTIG should be administered by a healthcare professional.

Each OPDIVO QVANTIG vial is for one-time use only. It is a ready-to-use solution for injection. It should not be diluted.

Visually inspect for particulate matter and discoloration prior to administration. OPDIVO QVANTIG is a clear to opalescent, colorless to yellow solution. Discard if the solution is discolored or contains extraneous particulate matter other than a few translucent-to-white particles. Do not shake.

Preparation

No incompatibilities were observed between OPDIVO QVANTIG and polypropylene and polycarbonate syringes, or between OPDIVO QVANTIG and polyethylene, polyurethane, polyvinyl chloride, and fluorinated ethylene propylene subcutaneous administration sets.

A syringe and a transfer needle are needed to withdraw OPDIVO QVANTIG solution from the vial. OPDIVO QVANTIG may be injected subcutaneously using a 23G-25G (3/8”-5/8”) hypodermic injection needle or subcutaneous administration set (eg., winged/butterfly).

•

600 mg nivolumab and 10,000 units hyaluronidase

∘: Allow 1 OPDIVO QVANTIG vial to reach room temperature, then withdraw 5 mL of OPDIVO QVANTIG into the syringe.

•

900 mg nivolumab and 15,000 units hyaluronidase

∘: Allow 2 OPDIVO QVANTIG vials to reach room temperature, then withdraw 5 mL from one vial and 2.5 mL from the other vial, for a total volume of 7.5 mL of OPDIVO QVANTIG into a single syringe.

•

1,200 mg nivolumab and 20,000 units hyaluronidase

∘: Allow 2 OPDIVO QVANTIG vials to reach room temperature, then withdraw 10 mL of OPDIVO QVANTIG into a single syringe.

Select the appropriate syringe label provided in the carton that matches the prescribed dose and apply to the prepared syringe.

Discard partially used or empty vials of OPDIVO QVANTIG.

If the dose is not to be used immediately, attach a tip cap to the syringe prior to storage. To avoid clogging of the hypodermic injection needle, attach a 23G-25G (3/8”-5/8”) hypodermic injection needle to the syringe immediately prior to administration.

Storage in Syringe

Once withdrawn into the syringe, OPDIVO QVANTIG should be used immediately. If not used immediately, store the syringe:

•: In the refrigerator at 2°C to 8°C (36°F to 46°F), protected from light for up to 48 hours; do not freeze, or
•: At room temperature 20°C to 25°C (68°F to 77°F) for up to 8 hours. Storage at room temperature for this duration does not require protection from light.
•: Discard if storage time exceeds these limits.
•: If stored in the refrigerator, allow the solution to come to room temperature before administration.

Administration

•: Administer the full contents of the syringe into the subcutaneous tissue of 1 of the 4 quadrants of the abdomen, or thigh over a period of 3 to 5 minutes.
•: Alternate injection sites across the 4 quadrants of the abdomen or thighs for successive injections. Do not inject into areas where the skin is tender, red, or bruised, or areas where there are scars or moles. If the administration of OPDIVO QVANTIG is interrupted, continue administering at the same site, or at an alternate site.
•: During treatment with OPDIVO QVANTIG, do not administer other subcutaneous medications at the same site used for OPDIVO QVANTIG.