TRODELVY (Sacituzumab Govitecan-Hziy)

TRODELVY is a medication specifically designed for the use in grown-ups who have metastatic triple-negative breast cancer. Individuals struggling with metastatic illness who have already attempted two or more treatments should be utilizing this option.

Triple-negative breast cancer is a form of breast cancer that is not responsive to the hormones estrogen and progesterone, as well as not expressing the HER2/neu gene.

How is this Drug Used?

TRODELVY is an injection. A healthcare worker administers the medication into a vein by injection every seven days on the first and eighth day of a 21-day period.

What are the Benefits of this Drug?

The study monitored what proportion of patients experienced a decrease in tumor size, either in its entirety or partially, after being treated (objective response rate). At the trial, nearly one-third of the 108 individuals taking TRODELVY saw either complete or partial shrinking of their tumors, and it continued for roughly 8 months.

TRODELVY was accepted by the FDA through the accelerated approval plan, granting individuals earlier access to a possible new medication while the company continues to research if the drug is successful.

How to Take TRODELVY

Sacituzumab govitecan-hziy is administered intravenously. The amount of the medicine will be determined by your weight, and your medical team will decide how often you will take it.

Before taking each dose, you will be given acetaminophen, diphenhydramine, a type of drug such as famotidine used to block histamine-2, and possibly a corticosteroid to stop any unwanted reactions. You will also receive medications to ward off nausea and throwing up. Make sure to tell your nurse or doctor immediately if you start to feel differently during the infusion. Be aware of any signs such as chills, a fever, nausea, having difficulty breathing, itching, redness, swelling in your face, lips, or tongue, or feeling like your chest and throat are tight.

Inform your provider before taking Sacituzumab govitecan-hziy if you have ever been told that you have a mutated version of the UGT1A1 gene, like homozygosity of the UGT1A1*28 allele. This can make it more likely for you to experience certain adverse effects.

This medication can have its potency altered by certain other medications, so it is best to stay away from them. These include carbamazepine, phenytoin, phenobarbital, rifampin, efavirenz, among others. Ensure you inform your medical practitioner about all the medications and additions you consume.

Possible Side Effects

There are various methods of dealing with the effects of Sacituzumab govitecan-hziy. Talk to your care team about these recommendations. They can assist you in determining what would be most suitable for you. These are some of the most common or important side effects:

Infection and Low White Blood Cell Count (Leukopenia or Neutropenia)

White blood cells (WBC) are important for fighting infection. While under medical care, it is possible for your white blood cell count to decrease, which would make you more vulnerable to catching an infection. It is essential to inform your medical provider immediately if you have a fever of 38°C or higher, a sore throat, cold, struggling for breath, cough, feeling pain when you pee, or any sores that won’t heal.

Tips for preventing infection:

Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
Avoid large crowds and people who are sick (i.e.: those who have a cold, fever, or cough or live with someone with these symptoms).
When working in your yard, wear protective clothing including long pants and gloves.
Do not handle pet waste.
Keep all cuts or scratches clean.
Shower or bath daily and perform frequent mouth care.
Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
Ask your oncology care team before scheduling dental appointments or procedures.
Ask your oncology care team before you, or someone you live with, has any vaccinations.

Diarrhea

Sacituzumab govitecan-hziy can lead to a substantial complication of diarrhea. It can lead to severe dehydration. Diarrhea is an increased frequency of defecation in a single day. Your healthcare supplier will give you instructions on how to use loperamide (an anti-diarrheal medicine) when you are at home, which you should begin to take as soon as diarrhea starts. Make sure to contact your provider if you haven’t been instructed to take an anti-diarrheal medication and your initial bout of diarrhoea happens.

Symptoms such as a runny nose, producing more saliva than usual, teary eyes, perspiration and abdominal cramping can occur within the initial day of taking this particular medication, along with diarrhea. If you experience any of these signs or symptoms during your infusion, alert your nurse. If you get diarrhea immediately, your medical personnel may provide medication at the clinic.

Nausea and/or Vomiting

Discuss with your cancer treatment team so they can provide medicines to help you deal with queasiness and throwing up. In addition, dietary changes may help. Stay away from items that could exacerbate symptoms, for example fatty, hot, or acidic ingredients (such as lemon, tomato, or orange). Try saltines, or ginger ale to lessen symptoms.

Contact your cancer treatment specialists if you’re unable to keep down any liquids for more than half a day or if you begin to feel dazed or faint at any moment.

Fatigue

It is quite typical to experience exhaustion while undergoing cancer treatment, which is a strong sense of tiredness that is not ordinarily relieved by getting some rest. While on the road to recovery from cancer treatment, and for a given number of months following, it may be necessary for you to adjust your daily routine in order to combat exhaustion. Set aside moments throughout the day to give yourself a break and save your energy for any essential tasks. Regular physical activity can help reduce weariness; going for a stroll each day with a companion may be beneficial. Consult your medical team for advice on how to manage this reaction.

Liver Toxicity

This medication may result in harm to the liver, which your oncology care team may look out for using blood tests known as liver function tests. Alert your medical professional if you witness jaundice of your skin or eyes, your urine has a dark or brown tint, or you have abdominal discomfort, since these may be warning signals of liver damage.

Low Red Blood Cell Count (Anemia)

The red blood cells in your body are accountable for transporting oxygen to your tissues. If your red cell count is decreased, you could experience fatigue or lack of strength. You should inform your oncology care team if you have any problems with breathing, such as feeling out of breath easily or in pain in the chest area. If your count is too low, you could be given a blood transfusion.

Loss or Thinning of Scalp and Body Hair (Alopecia)

Your hair may become weaker, more fragile, or may shed. This usually commences two to three weeks after the therapy begins. This kind of hair loss can involve any hair on the body, including in private areas, such as the pubic region, underarms, legs and arms, eyelashes, and even in the nostrils. Scarves, wigs, hats, and hairpieces can be employed to assist. Once treatment has finished, the process of hair regrowth usually begins soon afterwards. It is vital to wear a hat in cold temperatures or to guard your head from the sun, as your hair provides some insulation from the elements.

Infusion-Related Side Effects

A reaction to the infusion is possible, which might comprise of chills, fever, plummeting blood pressure, nausea, and vomiting. Ahead of the infusion, you will be given acetaminophen and diphenhydramine in order to try to stop any negative reactions. Some patients will also receive a steroid beforehand in order to stave off any sort of reaction. Responses occur frequently within the initial seven days of treatment, including the night following the infusion. Your oncology care team will indicate what steps to take if this occurs.

Constipation

Ways to avoid or reduce the effects of constipation include various strategies. Consume more fruits and vegetables for added fiber in your diet, drink at least 8-10 cups of non-alcoholic fluids throughout the day, and stay active. Taking a stool softener daily or every other day may help reduce the likelihood of suffering from constipation. If you haven’t had a bowel movement in two or three days, it is wise to talk to your medical team about methods to help with the blocked up feeling.

Rash

Certain individuals might experience a breakout, dry skin, or irritated red bumps. Apply a moisturizer that does not have alcohol in it to your skin and lips; stay away from moisturizers that have fragrances or aromas. If itching is causing issues, your oncology care team can suggest a topical treatment. If your skin has cracked or is bleeding, make sure to clean the area to keep it from becoming infected. You should inform your cancer treatment specialists immediately if you develop any kind of rash, since this may be a sign of a reaction. They can provide you with additional advice on how to take care of your skin.

Low Platelet Count (Thrombocytopenia)

Platelets are responsible for aiding the blood to clot, so an individual is more prone to bleeding when the count is diminished. Inform your cancer treatment staff if you experience any additional bruising or bleeding, like nose bleeds, bleeding gums, or discovering blood in your urine or excrement. If the amount of platelets in your body decreases to an unhealthy level, you may have to receive a blood transfusion of platelets.

Do not use a razor (an electric razor is fine).
Avoid contact sports and activities that can result in injury or bleeding.
Do not take aspirin (salicylic acid), non-steroidal, anti-inflammatory medications (NSAIDs) such as Motrin/Advil (ibuprofen), Aleve (naproxen), Celebrex (celecoxib) etc. as these can all increase the risk of bleeding. Please consult with your healthcare team regarding the use of these agents and all over the counter medications/supplements while on therapy.
Do not floss or use toothpicks and use a soft-bristle toothbrush to brush your teeth.

Decrease in Appetite

Nutrition is an important part of your care. Treatment for cancer can lessen one’s desire to eat, and in some instances the adverse effects of treatment may make it hard to eat. Inquire with your cancer care provider regarding the nutritional advice offered at the facility where you are receiving treatment to help you make wise dietary decisions.

Try to eat five or six small meals or snacks throughout the day, instead of 3 larger meals.
If you are not eating enough, nutritional supplements may help.
You may experience a metallic taste or find that food has no taste at all. You may dislike foods or beverages that you liked before receiving cancer treatment. These symptoms can last for several months or longer after treatment ends.
Avoid any food that you think smells or tastes bad. If red meat is a problem, eat chicken, turkey, eggs, dairy products and fish without a strong smell. Sometimes cold food has less of an odor.
Add extra flavor to meat or fish by marinating it in sweet juices, sweet and sour sauce or dressings. Use seasonings like basil, oregano or rosemary to add flavor. Bacon, ham and onion can add flavor to vegetables.

Aches and Headache

Sacituzumab Govitecan-hziy may trigger discomfort in the back, abdomen and head causing a disruption in the overall quality of life. Your doctor can suggest drugs and other approaches that can assist with alleviating pain.

High Blood Sugar

This medication can lead to an increase in blood sugar levels for individuals with and without diabetes. Your oncology care team will monitor your blood sugar. If you find yourself becoming excessively thirsty, needing to urinate or having excessive hunger, have blurry sight or have severe headaches or have a fruity smell coming out of your breath, tell your healthcare providers ASAP. Diabetics should keep a close eye on their blood sugar levels and tell their medical team if they go up.

Peripheral Neuropathy (Numbness or Tingling in the Hands and/or Feet)

Peripheral neuropathy is a toxicity that affects the nerves. One may experience a lack of sensation or a prickling sensation in their hands and/or feet, usually resembling a glove or stockinged foot. The situation could become increasingly worse if more doses of the medication are given. In certain individuals, the manifestations will disappear gradually when the drug is discontinued, however, others may never fully recover. It is essential to inform your cancer treatment team of any sensations of numbness or burning in your hands and/or feet, as they may need to regulate the quantity of drugs you are taking.

Dizziness

This medication can cause dizziness. Inform your healthcare practitioner if you feel lightheaded, particularly if it is making daily activities difficult.

Electrolyte Abnormalities

This medication can alter the standard concentrations of electrolytes (potassium, magnesium, calcium, etc.) in the body. Your levels will be monitored using blood tests. If your electrolyte counts become too low, your medical staff may recommend certain electrolytes to be received through intravenous injections or taken orally. Do not ingest any dietary supplements unless you have consulted with your medical personnel.

Sexual & Reproductive Concerns

This medication may affect your reproductive system and fertility. Discuss with your healthcare professional any worries you might have if you want to have kids in the future.

Taking this medication while pregnant or impregnating someone could result in birth defects, so you should not have a baby while using it. Women need to utilize effective forms of contraception during therapy and for at least a half-year after completing their treatment, even when the menstrual cycle has ceased. It is essential for men to practice effective contraception methods during treatment and for the next three months even if they assume they are not producing sperm. It is advised that you do not nurse while taking this medication and for a period of one month after your last dose.