Durvalumab: Uses, Dose, Side Effects, and Precautions

What Is Durvalumab?

Durvalumab is an immunotherapy drug that's basically a monoclonal antibody. Your doctor might prescribe it if you have non-small cell lung cancer after chemo and radiation, or for other advanced cancers.

You'll get this medication through an IV (intravenous) at your hospital; it's not a pill you can take home. Your immune system naturally fights cancer, but some cancer cells hide by making proteins that tell your immune system to back off. Durvalumab blocks these proteins, so your body can spot and attack the cancer cells as it should.

How Does Durvalumab Work?

If you're dealing with non-small cell lung cancer, your doctor might recommend Durvalumab as part of your treatment plan. Your cancer cells have this protein called PD-L1 (programmed death ligand) that basically helps them hide from your immune system.

Normally, PD-L1 acts like a stop sign, telling your body's T cells and other immune fighters to back off and not attack the cancer. But Durvalumab blocks PD-L1, keeping your immune cells fired up and ready to fight. Once those immune cells are active again, they can spot the cancer cells and go after them as they should.

Doctors call this type of medicine a checkpoint inhibitor because it removes those "stop signs" that cancer puts up to protect itself from your immune system.

Indications:

• Non-Small Cell Lung Cancer (NSCLC):

If you're dealing with stage III NSCLC that can't be removed surgically, and your cancer hasn't gotten worse after you've completed both platinum-based chemo and radiation together, this could be an option for you.

• Small Cell Lung Cancer:

For those of you facing extensive-stage small-cell lung cancer, this can be your first treatment approach. You'll use it alongside Etoposide and either Cisplatin or Carboplatin.

Dosage:

If you're dealing with non-small cell lung cancer (NSCLC), your dose will typically be 10mg/kg of your weight.

Most people get their infusions every two weeks. Sometimes, though, your doctor might space them out every four weeks, especially if you've been on combination therapy. When you're getting Durvalumab alongside chemotherapy for certain cancers, you might receive a higher fixed dose (like 1500 milligrams if you weigh 30 kg or more) every three weeks instead.

Your medical team might tweak your dose or schedule based on your specific cancer, how you're responding to treatment, your overall health, or any side effects you experience.

If you develop side effects during your infusion, your team might need to slow the infusion or temporarily stop the treatment.

Warnings and Precautions:

• If you notice a rash, itching, hives, or trouble breathing, you might be having an allergic reaction to the medication.
• Watch out for signs like a racing heartbeat, hair falling out, sudden weight changes, feeling extremely tired, dizzy, or fainting, constant headaches, constipation, nausea, or vomiting; these could mean your adrenal glands aren't working properly.
• If you're experiencing diarrhea, severe stomach pain, black stools, or stools containing blood or mucus, you may have colon inflammation.
• A persistent cough, shortness of breath, or chest pain might signal problems with your lungs.
• If you notice you're not urinating as much as usual, your kidneys might be affected.
• Nausea, vomiting, yellowing of your skin and eyes, or pale-colored stools could indicate liver issues.
• During your infusion, you might experience chills, shaking, flushing, wheezing, itching, rash, dizziness, or fever.
• Your blood sugar might spike, causing confusion, deep breathing, or a metallic taste in your mouth.
• You might bruise or bleed more easily if your platelet count drops.
• If you're able to get pregnant, you'll need to use reliable birth control during treatment and for at least three months after stopping, as this medication could harm a developing baby.

For Patients:

When and Why to Take Durvalumab?

When you are dealing with cancer, your doctor might recommend Durvalumab, which depends on what type you have and how far along it is. Sometimes you'll get it as part of your main treatment plan, and other times it comes after.

If you've got non-small cell lung cancer and you've just finished chemo and radiation, your doctor will usually wait until things have settled down and you're feeling better before starting Durvalumab.

For more advanced cancers that have spread, you might get Durvalumab by itself or mixed with other cancer-fighting drugs.

Durvalumab is mainly used for certain lung and bladder cancers. What's cool is that it's immunotherapy, basically, it helps your immune system fight cancer without the harsh cell damage you get with traditional treatments.

How Effective Is Durvalumab?

After two years of treatment, patients taking this medication had a 66.3% survival rate, which is significantly better than those who didn't get it. You're not just looking at living longer. Your cancer is also likely to stay under control for a much longer time compared to if you were just getting a placebo. Both your overall survival and the time before your cancer progresses improve with this treatment.

Things to Inform Your Doctor Before They Prescribe You Durvalumab

Inform your doctor if you have any of the following conditions:

• Previous history of allergy or hypersensitivity reactions to drugs.
• Have immune system conditions such as Crohn’s disease (a disease that affects your gastrointestinal system) or ulcerative colitis (inflammation of your colon and rectum).
• Have undergone or are scheduled for a stem cell transplant using donor stem cells.
• Have undergone radiation therapy for your chest area.
• Have a neurological disorder, such as myasthenia gravis (muscle weakness) or Guillain-Barré syndrome (neurological disorder).
• If expecting or intending to get pregnant, Durvalumab may harm the unborn child.
• Either currently breastfeeds or wants to do so. Whether Durvalumab enters breast milk is unknown. Avoid breastfeeding while receiving Durvalumab therapy and for at least three months following the final dosage.
• All medications you use, including prescription and over-the-counter medications, vitamins, and herbal supplements, should be mentioned to your doctor.

How Is Durvalumab Given?

You'll receive your Durvalumab treatment at a hospital. Your dose depends on how your doctor schedules it. You'll either get 10 mg per kilogram (given every 2 weeks) or a flat 1500 mg dose every 3 to 4 weeks.

Your doctor will set up an IV drip and let the medication flow into your vein. The whole process takes about an hour.

Things to Do After You Start Taking Durvalumab:

• Once the therapy begins, watch for any changes in symptoms.
• Inform your doctor if you experience any side effects so they can advise you on what to do.
• Your doctor will not be able to assess how well the medication works unless its effects are monitored and communicated clearly.

What Are the Side Effects Associated with Durvalumab?

The list of side effects is as follows:

Very Common Symptoms:

• Cough.
• Diarrhea.
• Fever.
• Upper respiratory tract infections.
• An underactive thyroid gland can result in fatigue or weight gain.
• Abdominal pain.
• Itching or a skin rash.
• Joint aches (arthralgia).

Common Symptoms:

• Severe respiratory infections (pneumonia), oral fungus, and soft tissue infections of the teeth and mouth.
• Muscle aches (myalgia).
• Flu-like conditions.
• An overactive thyroid gland can lead to weight loss or a rapid heartbeat.
• Lung inflammatory disease (pneumonitis).
• A raspy voice (dysphonia).
• Sweaty nights.
• Increased liver tests (aspartate aminotransferase increased; alanine aminotransferase increased).
• Alterations in kidney function testing (blood creatinine increased).
• Painful urination.
• Swelling in the leg.
• A response to a medication infusion that may result in fever or flushing.

Uncommon and Rare Symptoms:

• Inflammation of the thyroid gland, kidneys, gut, and muscle.
• Scarring of lung tissue.
• Decrease in the amount of urine.
• Loss of appetite.
• Increased blood sugar levels.
• Myasthenia gravis (a condition where muscles become weak, accompanied by extreme fatigue).
• Bladder inflammation.
• Meningitis.

When used in combination with other chemotherapeutic agents, the following side effects have also been observed:

• Hair loss.
• Cough.
• Decrease in blood counts.
• Diarrhea (loose stool).
• Skin rashes.
• Muscle ache.
• Joint pain.
• Abdominal pain.

Dietary Alterations:

You'll want to skip the alcohol completely while you're on this medication. It can make those side effects worse. You don't need to make any other major changes to your diet when taking Durvalumab.

Just focus on keeping your meals balanced, you know, getting all those vitamins and minerals your body needs to keep everything running smoothly.

What Should Be Done When You Miss a Dose?

If you happen to miss your Durvalumab dose, don't panic; just give your doctor a ring right away. Keeping up with your treatment schedule is important for your health. Your care team knows what they're doing, and they'll figure out the best and safest way to adjust your dosing timeline.

What Should Be Done to Treat Durvalumab Overdose?

If you think you've taken too much, get in touch with your doctor right away. Your medical team will focus on supporting you and helping manage any symptoms or side effects that arise.

Because Durvalumab works with your immune system, your doctors will want to watch out for any immune-related issues that might come up.

How to Store Durvalumab?

• Make sure you keep the vial out of reach of kids.
• You'll need to store it somewhere cold, between two and eight degrees Celsius.
• Just don't let it freeze.
• Keep it in the container it came in. This helps protect it from light, which can damage the medication.
• Before using it, take a quick look. If you notice it's cloudy, has changed color, or you can see particles floating around, don't use it.
• And once you've prepared your infusion solution, use it right away.

For Doctors:

Pharmokinetics

• After intravenous (IV) infusion, Durvalumab enters your bloodstream and circulates throughout your body.
• It is a monoclonal antibody, so it is broken down slowly by normal protein degradation pathways, rather than by the liver, as with many drugs.
• The half-life (time it takes for half the drug to leave the body) is approximately 17 days, which is why it is usually given every two to four weeks.
• The drug is cleared gradually, and the dosing schedule maintains effective levels in the body.
• Kidney or liver function usually does not require major dose adjustments, but your doctor will monitor for safety.

Absorption

Since Durvalumab is a special type of medicine called a monoclonal antibody, you can't just swallow it like a regular pill. Your doctor will give it to you through an IV drip straight into your bloodstream. This way, your body gets the full dose right away without going through your stomach first.

Metabolism

When Durvalumab enters your bloodstream, your body processes it just like other proteins. Your liver and immune system break it down into smaller peptides and amino acids. Your body then recycles these pieces or simply gets rid of them. What's great is that durvalumab doesn't get broken down by your liver's cytochrome P450 enzymes (unlike many regular drugs), so you won't have to worry much about drug interactions.

Distribution

The geometric mean steady-state volume of distribution was 5.6 L (18 percent).

Elimination

Based on the baseline clearance, Durvalumab had a total body clearance of 8.2 mL/hr (milliliters per hour). The elimination half-life of Durvalumab is 18 days.

Drug Interactions

The drug interactions of Durvalumab are as follows:

• Adalimumab.
• Betamethasone.
• Budesonide.
• Cortisone.
• Dexamethasone.
• Deflazacort.
• Etanercept.
• Prednisone.

Other Specifications

• Durvalumab in Pregnant and Lactating Women:

If you are pregnant or thinking about becoming pregnant, no study reveals this medication affects expecting moms yet, but there's a real possibility it could harm your baby. And if you're breastfeeding, you'll need to stop while you're on this drug.

• Durvalumab in Pediatric Patients:

There is not enough information about how safe or effective Durvalumab is for anyone under 18. Doctors won't prescribe it for pediatric patients.

• Durvalumab in Geriatric Patients:

If you're in your golden years, you don't need any special adjustments. Studies haven't shown any major differences in how your body processes this medication compared to younger people.

• Durvalumab in Renal Impairment Patients:

If you have kidney issues, you can breathe easy on this one. You won't need your dose adjusted just because of kidney impairment.