Vonjo

Generic Name Pacritinib
Dosage Form Capsules

Medically evaluated by S Shah MD. The last update was on March 18, 2022.

What is Vonjo?

Vonjo is a prescription medication that is used to treat patients with certain forms of myelofibrosis that are platelet-positive and have platelets less than 50 x ^9./L.

It isn’t known whether this medication has been proven safe or effective for children.

VONJO contains pacritinib citrate, a kinase inhibitor with the chemical name (2E,16E)-11-[2- (pyrrolidin-1-yl)ethoxy]-14,19-dioxa-5,7,27-triazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa- 1(25),2,4,6,8,10,12(26),16,21,23-decaene citrate and a molecular weight of 664.7 as citrate salt and 472.59 as a free base.

VONJO capsules are intended to be taken orally. Each capsule has 100 mg pacritinib which is equivalent up to 140.65 milligrams of the drug pacritinib. The inactive ingredients are microcrystalline , cellulose (NF), polyethylene glycol 8000 (PEG 8000) in NF and magnesium stearate. Gelatin capsules are bovine-derived. The capsule shell is made up of Gelatin, Titanium dioxide the black oxide of iron, erythrosine red iron oxide, and printing ink that contains propylene glycol and shellac. sodium hydroxide, titanium dioxide, and povidone.

Mechanism of Action

Pacritinib is an oral kinase inhibitor with activity against wild type Janus associated kinase 2 (JAK2), mutant JAK2V617F, and FMS-like tyrosine kinase 3 (FLT3), which contribute to signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. MF is often associated with dysregulated JAK2 signaling. Pacritinib has higher inhibitory activity for JAK2 compared to JAK3 and TYK2. At clinically relevant concentrations, pacritinib does not inhibit JAK1. Pacritinib exhibits inhibitory activity against additional cellular kinases (such as CSF1R and IRAK1) the clinical relevance of which is unknown.

Before you take Vonjo

Before starting treatment, inform your doctor about all your medical conditions, especially the following:

• Smoke or were smokers in the past
• Have you had any other cancers? Check out the risk of developing new (secondary) types of cancer under the heading Vonjo adverse effects.
• may have suffered from a blood clot or heart attack, as well as other heart issues or stroke,
• are suffering from an infection. You can find the risk of the infection under the heading Vonjo adverse effects.
• are prone to diarrhea, or have loose or loose stools.
• are nauseated or nausea or vomiting
• suffer from active bleeding, have experienced severe bleeding, or are planning to undergo surgery. It is recommended to stop taking Vonjo 7 days prior to any surgery or other surgical procedure that is invasive (such as a coronary catheterization, stent placement within the coronary artery of the heart, or an operation to treat the treatment of varicose veins).
• suffer from kidney or liver issues
• Are pregnant or planning to be pregnant or plan to. It isn’t clear whether Vonjo can harm your baby
• If you are nursing or planning to or plan to. It’s not clear whether Vonjo gets into your milk. It is not recommended to give birth during treatment or for two weeks following your last dose. Consult your healthcare provider regarding the best method to feed your child during this time.

What other drugs can be affecting Vonjo?

Discuss with your doctor any medications you are taking that are prescription or over-the-counter medications such as vitamins, herbal supplements. The combination of Vonjo together with other medications could affect the amount of Vonjo present in blood and increase the chance of experiencing side effects or alter the way Vonjo performs.

Take note of the medicines you are taking. Keep a record of the medications you are taking to show your doctor and pharmacist if you are given additional medication.

Inform your doctor of the medications you take, especially of these medications:

• Antibiotics macrolide (clarithromycin, the erythromycin)
• antifungal medicines (itraconazole, ketoconazole, posaconazole, voriconazole)
• HIV drugs that include atazanavir, darunavir, efavirenz indinavir, etravirine Nelfinavir, nevirapine, ritona cobicistat, saquinavir or
• blood pressure or heart-related medicines (quinidine, amiodarone and diltiazem verapamil, quinidine)
• cimetidine
• Mifepristone
• Nefazodone
• cannabidiol
• Cyosporine
• Phenytoin
• rifampin

What should I do to consume Vonjo?

• Take Vonjo exactly according to what your physician advises you to do.
• Do not alter your dosage or stop treatment without speaking with your healthcare professional.
• If you’re taking other inhibitors of kinase, follow your physician’s advice regarding how to slowly reduce (taper) the dosage or stop other medicines that inhibit kinase prior to starting Vonjo.
• Vonjo capsules are typically taken in two doses throughout the day.
• Take the capsules in one swallow. Do not break, open or chew capsules.
• The capsules can be taken either with food or not.
• Your dose should be taken around the same time throughout the day.
• When you observe any changes in the frequency of your bowel movements, especially when they become more swollen or you experience diarrhea, begin taking an antidiarrheal drug (for instance loperamide) immediately you begin to notice changes according to the instructions of your physician.
• If you are taking too much or are taking an overdose If you are experiencing an overdose or a dose of too much, contact your physician or go to an emergency room immediately and bring the container from Vonjo to take with you.
• If you do not take your dose, do not take the missed dose and take the next dose at the regular time. Do not take two doses at once to cover the dose you missed.
• Your physician will perform tests on your blood prior to starting or as required throughout your treatment.
• Your doctor may alter the dosage or frequency you take Vonjo and may temporarily or completely stop treatment in the event that you experience certain adverse consequences.¶

Dosing information

Recommended Dosage

• The dosage recommended for VONJO of 200mg taken orally every day, twice. VONJO is a supplement to and without meals.
• Consume capsules completely. Do not break, open and chew them.
• Patients on treatment with other kinase inhibitors prior to the start of VONJO must stop or taper according to the prescription information for the medication.

Monitoring for Safety

• Completely count your blood (CBC including the white blood cell count, its differential and count of platelets) and coagulation tests (prothrombin timing, partial thromboplastin times, thrombin timing and the International Normalized Ratio) and an electrocardiogram baseline (ECG) prior to beginning VONJO and then monitor the results for clinical indications during the course of treatment.

Missed Dose

• If the dosage of VONJO is missed, the patient must get the next dose at the scheduled time. Additional capsules shouldn’t be consumed to make up the dose that was missed.

Dose Interruption For Planned Surgical Procedures Or Other Interventions

• Do not discontinue VONJO 7 days before elective surgery or other invasive procedures due to the risk of hemorrhage. You should restart the procedure only when hemostasis has been confirmed.

Vonjo side effects

Vonjo can have severe side effects, including:

• bleeding. Vonjo may cause massive bleeding that can be dangerous and in certain instances, may result in death. Do not take Vonjo in the event that you are bleeding. If you notice bleeding, stop the treatment and contact your doctor. Your healthcare provider will perform an analysis of blood to assess your blood cell count prior to when you begin treatment, and then often throughout the course of your treatment. Inform your doctor immediately if you notice any of the following symptoms: bleeding that is unusual or swelling, as well as fever. You must stop taking Vonjo seven days prior to any surgical or other procedure (such as the heart catheterization procedure or stent placement within the coronary artery of your heart or an operation for varicose veins). Your physician should inform you when you are able to begin taking Vonjo once more.
• Diarrhea. Diarrhea is typical of Vonjo however it can be very severe and lead to the loss of excess liquid in the body (dehydration). Inform your doctor that you are suffering from diarrhea and follow the instructions on what you can do to combat diarrhea. Take plenty of water in order to avoid dehydration. Your doctor may alter the dosage if you experience severe diarrhea.
• Lowering platelet counts. Your healthcare provider will conduct tests on your blood to determine your blood counts prior to when you begin your treatment and also during treatment.
• The changes within the heart’s electrical activities are known as QTc extension. QTc prolongation can cause irregular heartbeats, which can be life-threatening. Your doctor will test the heart’s electrical activity by performing a test known as the electrocardiogram (ECG) before you begin treatment, and throughout the course of treatment when necessary. If you’ve had a history or a history of low potassium levels in your blood it is crucial to take your blood tests according to the instructions of your physician to track the body’s sodium (electrolytes) within your blood. Contact your healthcare provider immediately if you begin to feel faint, dizzy, or faint.
• Greater risk of major cardiovascular events, such as stroke, heart attack, or death among people who are at risk for cardiovascular disease and who are either current or have been smokers for a while or have occurred in some individuals using another JAK inhibitor in order to treat rheumatoid arthritis.
  Seek emergency assistance immediately should you show any indications of a heart attack stroke when taking Vonjo for example:
  • an ache in the center of your chest, which lasts for more than a couple of minutes, or is gone and then returns
  • intense tightness, pain tension, or heaviness in your throat, chest neck, jaw, or chest
  • discomfort or pain in your back, arms or neck, jaw or stomach
  • shortness of breath, with the or without discomfort in your chest
  • exchanging an uncontrollable sweat
  • nausea or vomiting
  • Feeling faint and lightheaded
  • an area of weakness or one of the sides of your body
  • Slurred speech
• Risk of blood clots increasing. Blood clots within the veins in your legs (deep vein thrombosis, also known as DVT) or in the lungs (pulmonary embolism PE) occur in a few patients who take another JAK inhibitor. These can be life-threatening. Contact your physician whether you’ve experienced blood clots within blood vessels of your lungs or legs previously.
  Inform your doctor immediately if you exhibit any symptoms or signs of blood clots forming during treatment, including:
  • swelling tenderness, pain, or swelling in both legs or one
  • unintentional, inexplicably painful chest pain that is not explained
  • Breathing difficulty or slurred breathing
• Potentially increased risk of developing new (secondary) types of cancer. People who take another JAK inhibitor for rheumatoid arthritis are at an increased chance of developing new (secondary) tumors such as lymphoma, as well as other cancers, excluding the non-melanoma type of skin cancer. The risk of developing new cancers is increased even more in those who smoke or used to smoke in the previous time.
• Risk of Infection. Individuals with certain blood cancers and who take another JAK inhibitor, are at an increased risk of getting serious infections. Infections are not uncommon, but those taking Vonjo could also be susceptible to serious infections like fungal, mycobacterial, bacterial, or viral illnesses. If you are suffering from serious infections Your healthcare provider might not prescribe Vonjo until the illness is gone. Your healthcare provider will be monitoring you and treating any infections you may receive while you are receiving treatment.
  Contact your healthcare provider immediately if you notice any of these symptoms of the infection:
  • chills
  • Aches
  • The fever
  • nausea
  • vomiting
  • weaknesses
  • painful skin rash or blisters

The most commonly reported adverse effects are:

• nausea and vomiting
• low count of red blood cells (anemia)
• swelling in your legs, ankles, and feet

Vonjo can alter the fertility of males. It is possible that you will have issues fathering children. Consult your doctor to discuss this concern for you.

They aren’t all the possible adverse negative effects. Consult your physician to seek medical advice on adverse effects. You can report any symptoms to FDA at 1-800-FDA-1088.¶

Storing Vonjo

• Keep Vonjo capsules on the ice at room temperatures, at or below 86 deg F (30degC).
• Place the capsules in the original container.
• Close the bottle tightly to shield the capsules from light.

Make sure that all medications are away from pets and children.

General information on the safety of Vonjo.

Sometimes, medicines are used for reasons other than those stated in the Patient Information leaflet. Use this medication only to treat a problem for which it is not recommended. Don’t give it to others even if they suffer from similar symptoms to those you do. It may cause harm to them.

Your physician or pharmacist for any information designed for health professionals.

What are the main ingredients that makeup Vonjo?

Active ingredient: pacritinib
Ingredients that are inactive: microcrystalline cellulose, polyethylene glycol 8000 (PEG 8000), and magnesium Stearate. The capsule shell is made up of gelatin, titanium dioxide black iron oxide, and erythrosine red iron oxide, and printing inks that contain titanium dioxide, shellac propylene glycol, sodium hydroxide, and povidone.

Label

Package Label – 25 mg – 60 Capsules

• NDC 71777-390-01
• VITRAKVI®
• (larotrectinib) capsules
• 25 mg
• Usual Dosage: See prescribing information. Rx only.
  60 capsules. Keep out of reach of children.
  Store at 20°C to 25°C (68°F to 77°F).
  Excursions permitted from 15°C to 30°C (59° to 86°F).
• Manufactured for Loxo Omcology, Inc. Stamford, CT 06901      86579626
• (01)10371777390012
• Bayer
• LOXO
• Each capsule contains
  25 mg larotrectinib
  (equivalent to 30.7 mg
  larotrectinib sulfate).

Package Label – Carton – 100 mg – 60 Capsules

• VITRAKVI®
• (larotrectinib) capsules
• 100 mg
• Each capsule contains 100 mg larotrectinib
  (equivalent to 123 mg larotrectinib sulfate).
• -60 capsules
  -oral use

SRC: NLM .