Kcentra: Side Effects, Dosage, Warnings

Kcentra: Side Effects, Dosage, Warnings

What is Kcentra?

Kcentra is brand name of Prothrombin Complex Conc (Human). (generic name: Prothrombin Complex Concentrate (Human) brand name: kcentra).

PROTHROMBIN COMPLEX CONCENTRATE (proh THROM bin KUM pleks KON suhn treyt) is used in patients who are taking a vitamin K antagonist like warfarin to stop bleeding or when urgent surgery is needed.

Kcentra is a purified, heat-treated, nanofiltered and lyophilized non-activated four-factor Prothrombin Complex Concentrate (Human) prepared from human U.S. Source Plasma (21 CFR 640.60). It contains the Vitamin K Dependent Coagulation Factors II, VII, IX and X, and the antithrombotic Proteins C and S. Factor IX is the lead factor for the potency of the preparation as stated on the vial label. The excipients are human antithrombin III, heparin, human albumin, sodium chloride, and sodium citrate. Kcentra is sterile, pyrogen-free, and does not contain preservatives. The product contents are shown in Table 7 and listed as ranges for the blood coagulation factors.

FDA Approves Kcentra: The U.S. Food and Drug Administration has approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States.

It is used to undo the effects of certain blood thinners like warfarin. Patients receiving chronic anticoagulation therapy with warfarin and other VKA anticoagulants to prevent blood clotting in conditions such as atrial fibrillation or the presence of an artificial heart valve sometimes develop acute bleeding. Like plasma, Kcentra is used in conjunction with the administration of vitamin K to reverse the anticoagulation effect and stop the bleeding. Unlike plasma, Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma.

Kcentra is associated with the occurrence of blood clots when used as indicated, and carries a boxed warning regarding the risk of blood clots. The warning also explains that patients receiving Kcentra should be monitored for signs and symptoms of thromboembolic events, as both fatal and non-fatal arterial and venous thromboembolic complications have been reported in clinical trials and post marketing surveillance.

Kcentra is made from the pooled plasma of healthy donors. It is processed in a way to minimize the risk of transmitting viral and other diseases. The FDA approval of Kcentra was based on a study of 216 patients who had been receiving VKA anticoagulation and who had acute major bleeding along with a clotting test value indicative of anticoagulant use. Kcentra was demonstrated to be similar to plasma in terms of the ability to stop acute major bleeding.

Use Kcentra (prothrombin complex conc (human) [(factors II, VII, IX, X), prot C, prot S]) as ordered by your doctor. Read all information given to you. Follow all instructions closely. It is given as an infusion into a vein over a period of time. if you miss a dose call your doctor to find out what to do.

if you suspected to overdose call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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Dosage of Kcentra

The actual potency per vial of Factors II, VII, IX and X, Proteins C and S is stated on the carton.

Individualize Kcentra dosing based on the patient's current pre-dose International Normalized Ratio (INR) value, and body weight.

Administer Vitamin K concurrently to patients receiving Kcentra. Vitamin K is administered to maintain Vitamin K-dependent clotting factor levels once the effects of Kcentra have diminished.

Repeat dosing with Kcentra is not supported by clinical data and is not recommended.

Dose ranging other than what is recommended has not been studied in randomized clinical trials of Kcentra.

Reconstitute Kcentra with 20 mL of diluent (Sterile Water for Injection, USP) provided with the kit. When reconstituted, the final concentration of drug product in Factor IX units will be in a range from 20-31 units/mL, depending on the actual potency, which is listed on the carton.

Side effects of Kcentra

The most common adverse reactions (ARs) (frequency ≥ 2.8%) observed in subjects receiving Kcentra were headache, nausea/vomiting, arthralgia, and hypotension.

CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Flushing.

A fast heartbeat.

Anxiety.

Very upset stomach or throwing up.

Very bad dizziness or passing out.

Fast breathing.

Very bad headache.

Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.

Feeling very tired or weak.

Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Headache.

Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

Kcentra

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Warnings of Kcentra

People are treated with drugs to thin the blood when they have health problems that raise the chance of blood clots. This medicine is used to undo the effects of those drugs. Very bad and sometimes deadly blood clots have happened after using Kcentra (prothrombin complex conc (human) [(factors II, VII, IX, X), prot C, prot S]). Talk with your doctor, if you have ever had a blood clot.

Before you use Kcentra (prothrombin complex conc (human) [(factors II, VII, IX, X), prot C, prot S]), tell your doctor if you have had a heart attack, a blood problem called disseminated intravascular coagulation (DIC), stroke, chest pain, or very bad blood vessel disease within the past 3 months. You will need to talk about the benefits and risks of using Kcentra (prothrombin complex conc (human) [(factors II, VII, IX, X), prot C, prot S]).

If your symptoms or health problems do not get better or if they become worse, call your doctor.

Do not share your drugs with others and do not take anyone else's drugs.

Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.

Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.

Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.

Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Kcentra (prothrombin complex conc (human) [(factors II, VII, IX, X), prot C, prot S]), please talk with your doctor, nurse, pharmacist, or other health care provider.

Kcentra while Pregnancy

Prothrombin complex concentrate is not recommended unless clearly needed.

Animal reproduction studies have not been conducted. It is not known whether prothrombin complex concentrate can cause fetal harm when administered to a pregnant woman or if it may affect reproduction. Prothrombin complex concentrate should be prescribed for a pregnant woman only if clearly needed.

FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: C

Breastfeeding: Use only if clearly needed.

Excreted into human milk: Unknown

Excreted into animal milk: Unknown

The effects in the nursing infant are unknown.

these drugs may interact with prothrombin complex so be carefull:

aminocaproic acid (Amicar)

aprotinin (Trasylol)

argatroban (Acova)

carfilzomib (Kyprolis)

coagulation factor x (Coagadex)

emicizumab (Hemlibra)

lepirudin (Refludan)

tranexamic acid (Lysteda, Cyklokapron).

Kcentra

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