Opdivo Qvantig

Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) is a subcutaneous (under the skin) form of Opdivo used to treat many cancers, including kidney cancer (renal cell carcinoma), melanoma, non-small cell lung cancer, head and neck cancer, urothelial (bladder and urinary tract) cancer, colorectal cancer, liver cancer, esophageal cancer, and gastric cancer. It is given by a healthcare professional as an injection into the abdomen or thigh over 3 to 5 minutes.

Opdivo Qvantig contains 2 medicines. Nivolumab is a PD-1 blocking antibody that releases a brake on the immune system so it can attack cancer cells. Hyaluronidase is an enzyme that temporarily increases the permeability of tissue under the skin, allowing a large dose of nivolumab to be given as a subcutaneous injection.

Adults already receiving intravenous nivolumab alone, or with chemotherapy or cabozantinib, may switch to Opdivo Qvantig at their next scheduled dose. Opdivo Qvantig is not approved for use in combination with ipilimumab (Yervoy).

Opdivo Qvantig (nivolumab and hyaluronidase) gained FDA approval on December 27, 2024. There is no generic.

• Opdivo infusion was FDA-approved on December 22, 2014, and is administered intravenously.

Opdivo Qvantig is FDA-approved for the following cancers:

• Renal cell carcinoma (RCC) Intermediate- or poor-risk advanced RCC in adults as a first-line treatment following combination treatment with intravenous nivolumab and ipilimumab. Not approved for use in combination with ipilimumab. Advanced RCC in adults as a first-line treatment in combination with cabozantinib. Advanced RCC in adults who have received prior anti-angiogenic therapy.
• Melanoma Unresectable or metastatic melanoma in adults and children 12 years and older (30 kg [66 lb] or more). Unresectable or metastatic melanoma in adults and children 12 years and older (30 kg or more) following combination treatment with intravenous nivolumab and ipilimumab. Not approved for use in combination with ipilimumab. Completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma in adults and children 12 years and older (30 kg or more), as adjuvant treatment after surgery.
• Non-small cell lung cancer (NSCLC) Resectable (tumors 4 cm or larger or node positive) NSCLC in adults, in the neoadjuvant setting (before surgery), in combination with platinum-doublet chemotherapy. Resectable (tumors 4 cm or larger or node-positive) NSCLC in adults with no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment in combination with platinum-doublet chemotherapy, followed by Opdivo Qvantig alone as adjuvant treatment after surgery. Metastatic NSCLC in adults with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations before receiving Opdivo Qvantig. Not approved for use in combination with ipilimumab.
• Squamous cell carcinoma of the head and neck (SCCHN) Recurrent or metastatic SCCHN in adults with disease progression on or after a platinum-based therapy.
• Urothelial carcinoma (UC) UC in adults at high risk of recurrence after undergoing radical resection of UC, as adjuvant treatment. Unresectable or metastatic UC in adults as first-line treatment in combination with cisplatin and gemcitabine. Locally advanced or metastatic UC in adults who: have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
• Colorectal cancer (CRC) Unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) CRC in adults and children 12 years and older (30 kg or more) following combination treatment with intravenous nivolumab and ipilimumab. Not approved for use in combination with ipilimumab. MSI-H or dMMR metastatic CRC in adults and children 12 years and older (30 kg or more) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Not approved for use in combination with ipilimumab.
• Hepatocellular carcinoma (HCC) Unresectable or metastatic HCC in adults as a first-line treatment following combination treatment with intravenous nivolumab and ipilimumab. Unresectable or metastatic HCC in adults who have been previously treated with sorafenib, following combination treatment with intravenous nivolumab and ipilimumab. Not approved for use in combination with ipilimumab.
• Esophageal cancer Completely resected esophageal or gastroesophageal junction cancer in adults with residual pathologic disease who have received neoadjuvant chemoradiotherapy (CRT). Unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) in adults as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy, whose tumors express PD-L1 (1 or more). Not approved for use in combination with ipilimumab. Unresectable advanced, recurrent, or metastatic ESCC in adults after prior fluoropyrimidine- and platinum-based chemotherapy.
• Gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma Advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in adults whose tumors express PD-L1 (1 or more), in combination with fluoropyrimidine- and platinum-containing chemotherapy.

Opdivo Qvantig has different dosage and administration instructions than intravenous nivolumab products.

• Opdivo Qvantig is for subcutaneous use only, in the abdomen or thigh.
• Opdivo Qvantig is to be administered by a healthcare professional only.

Tests before treatment

For esophageal squamous cell carcinoma, and for gastric, gastroesophageal junction, and esophageal adenocarcinoma, Opdivo Qvantig with chemotherapy is used only when tumors express PD-L1 (a PD-L1 score of 1 or more). For colorectal cancer, the tumor must be MSI-H or dMMR.

Opdivo Qvantig is a medicine that may treat certain cancers by working with your immune system. Opdivo Qvantig can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time. Some of these problems may happen more often when Opdivo Qvantig is used in combination with another therapy. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

• Lung problems: cough shortness of breath chest pain
• Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual stools that are black, tarry, sticky, or have blood or mucus severe stomach-area (abdominal) pain or tenderness
• Liver problems: yellowing of your skin or the whites of your eyes dark urine (tea colored) severe nausea or vomiting bleeding or bruising more easily than normal pain on the right side of your stomach area (abdomen)
• Hormone gland problems: headaches that will not go away or unusual headaches urinating more often than usual hair loss eye sensitivity to light eye problems rapid heartbeat increased sweating extreme tiredness weight gain or weight loss feeling cold constipation your voice gets deeper dizziness or fainting changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness feeling more hungry or thirsty than usual
• Kidney problems: decrease in the amount of your urine swelling of your ankles blood in your urine loss of appetite
• Skin problems: rash itching skin blistering or peeling painful sores or ulcers in your mouth or nose, throat, or genital area fever or flu-like symptoms swollen lymph nodes

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Opdivo Qvantig. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:

• chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• persistent or severe muscle pain or weakness, muscle cramps
• low red blood cells, bruising

Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor, depending on the type of organ or tissue transplant that you have had.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during treatment with Opdivo Qvantig. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Opdivo Qvantig if you have severe side effects.

Before receiving Opdivo Qvantig, tell your healthcare provider about all of your medical conditions, including if you:

• have immune system problems such as Crohn's disease, ulcerative colitis, or lupus
• have received an organ or tissue transplant, including a corneal transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area in the past and have received other medicines that are like Opdivo Qvantig
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant. Opdivo Qvantig can harm your unborn baby. Females who can become pregnant: Your healthcare provider should do a pregnancy test before you start receiving Opdivo Qvantig. You should use an effective method of birth control during treatment and for 5 months after your last dose of Opdivo Qvantig. Talk to your healthcare provider about birth control methods that you can use during this time. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Opdivo Qvantig.
• are breastfeeding or plan to breastfeed. It is not known if Opdivo Qvantig passes into your breast milk. Do not breastfeed during treatment and for 5 months after your last dose of Opdivo Qvantig.

It is not known if Opdivo Qvantig is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.

It is not known if Opdivo Qvantig is safe and effective in children for the treatment of any other cancers that it is used to treat in adults.

Most common side effects

The most common side effects of Opdivo Qvantig used alone in people with kidney cancer are muscle, bone, and joint pain, tiredness, itching, rash, low thyroid hormone levels, diarrhea, cough, and stomach-area (abdominal) pain.

Serious side effects occurred in 28% of people receiving Opdivo Qvantig, and 10% stopped treatment because of a side effect, most often pneumonitis (lung inflammation).

For its other uses, the safety of Opdivo Qvantig is based on intravenous nivolumab. When used with other medicines, side effects also depend on the combination:

• With cabozantinib (kidney cancer): diarrhea, tiredness, liver problems, redness, pain, swelling, or blisters on the palms or soles, mouth sores, rash, high blood pressure, low thyroid, and change in taste.
• With chemotherapy (lung, urothelial, esophageal, or gastric cancer): nausea, constipation, tiredness, decreased appetite, rash, vomiting, mouth sores, and numbness, pain, tingling, or burning in the hands or feet.

Serious side effects and warnings

See Important information above. Other serious side effects that can happen with Opdivo Qvantig include:

• Complications in stem cell transplant recipients. Complications, including graft-versus-host disease (GVHD), have occurred in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. They may happen if you had the transplant either before or after being treated with Opdivo Qvantig. Your healthcare provider will monitor you for these complications.
• Severe skin reactions. Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS, have occurred with PD-1 blocking medicines. Get medical help right away if you have skin blistering or peeling, painful sores in the mouth, nose, throat, or genital area, fever, or swollen lymph nodes.
• Increased risk of death in multiple myeloma. Adding a PD-1 blocking antibody, including nivolumab, to a thalidomide-type medicine plus dexamethasone increased deaths in clinical trials in people with multiple myeloma. This combination is not recommended outside of clinical trials.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Opdivo Qvantig may cause harm to an unborn baby. Females who can get pregnant should use effective birth control during treatment and for 5 months after the last dose.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Opdivo Qvantig (nivolumab and hyaluronidase) contains two ingredients, nivolumab and hyaluronidase.

Nivolumab is a laboratory-made antibody that helps the immune system fight cancer. Some tumors produce proteins called PD-L1 and PD-L2 that bind to PD-1 receptors on T cells, essentially telling these immune cells to stand down. This prevents T cells from multiplying and attacking tumors. Nivolumab blocks this interaction by attaching to the PD-1 receptor, releasing the brakes on the immune system and allowing T cells to recognize and fight cancer cells.

Hyaluronan is a gel-like substance found in the tissue under the skin, where it is naturally broken down and replaced, with a half-life of about half a day. The hyaluronidase in Opdivo Qvantig temporarily breaks down hyaluronan at the injection site, making the tissue more permeable so the medicine can spread and be absorbed. The effect is temporary and local, and the tissue returns to normal within 24 to 48 hours.

Opdivo Qvantig belongs to the drug class called immune checkpoint inhibitors. It may also be called a monoclonal antibody, PD-1 blocking antibody, or PD-1 inhibitor. Hyaluronidase is an endoglycosidase.

Opdivo Qvantig was compared with intravenous nivolumab in CheckMate-67T, a trial of 495 adults with advanced or metastatic clear cell kidney cancer who had received prior treatment.

• Blood levels of nivolumab with Opdivo Qvantig were at least as high as with the intravenous infusion, which was the main goal of the trial.
• Tumors shrank in 24% of people receiving Opdivo Qvantig, compared with 18% receiving intravenous nivolumab.

For its other approved uses, Opdivo Qvantig is supported by earlier trials of intravenous nivolumab, together with the blood level and safety results from CheckMate-67T.

Your healthcare provider will give you Opdivo Qvantig as an injection under the skin, in the stomach area (abdomen) or thigh, over about 3 to 5 minutes.

• Opdivo Qvantig is usually given every 2, 3, or 4 weeks, depending on the dose you are receiving.
• Your healthcare provider will decide how many treatments you need.
• Your healthcare provider will do blood tests to check you for side effects.
• For a type of kidney cancer called advanced renal cell carcinoma, your healthcare provider may also prescribe you cabozantinib (Cabometyx). Take cabozantinib exactly as your healthcare provider tells you.

Dosing information

Opdivo Qvantig is given as a subcutaneous injection over 3 to 5 minutes. Doses below refer to the nivolumab content. See the Opdivo Qvantig Prescribing Information for complete dosing.

• You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Opdivo Qvantig.
• Opdivo Qvantig can cause side effects in many different parts of your body. You may be given medication to prevent certain side effects, and your cancer treatments may be delayed if you need treatment for a side effect.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

See the Opdivo Qvantig Prescribing Information for more information.

Active ingredients: nivolumab and hyaluronidase-nvhy

Inactive ingredients: histidine, histidine hydrochloride monohydrate, methionine, pentetic acid, polysorbate 80, sucrose, and Water for Injection.

Opdivo Qvantig injection is available in two strengths:

• 300 mg nivolumab and 5,000 units hyaluronidase per 2.5 mL (120 mg/2,000 units per mL) in a single-dose vial
• 600 mg nivolumab and 10,000 units hyaluronidase per 5 mL (120 mg/2,000 units per mL) in a single-dose vial

Storage

Opdivo Qvantig vials are stored by the clinic in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze or shake.