Moxetumomab Pasudotox-tdfk and Sitavig

• Generic Name: moxetumomab pasudotox
• Dosage Forms: n.a.
• Other Brand Names: Lumoxiti

Moxetumomab pasudotox-tdfk is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).

Moxetumomab pasudotox-tdfk has the following limitations of use:

Not recommended in patients with severe renal impairment (CrCl ≤ 29 mL/min).

• Generic Name: acyclovir
• Dosage Forms: tablet, orally disintegrating, delayed release
• Other Brand Names: Sitavig, Zovirax

Sitavig is a prescription medicine used to treat cold sores (herpes labialis) in adults with normal immune systems. It is not known if it is safe and effective in children.

Do not use this medicine if you are allergic to:

acyclovir or any of the ingredients in Sitavig. See the end of this leaflet for a complete list of ingredients. milk protein concentrate

Before using Sitavig, tell your healthcare provider about all of your medical conditions, including if you:

are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements.

See the detailed Instructions for Use for information about how to use this medicine.

Use exactly as your healthcare provider tells you to use it. Use within one hour after you have the first symptom of a cold sore, such as itching, redness, burning, or tingling, and before a cold sore appears. You may eat and drink while using Sitavig. Do not crush, chew, suck, or swallow the tablets. Sitavig will slowly dissolve over time while in your mouth and should be left in place. Gently rinse your mouth with water to clean your teeth while Sitavig is in place. Drink more liquids if your mouth becomes dry while using Sitavig.

You should avoid activities that may prevent Sitavig from sticking to your gum, including: touching or pressing Sitavig after you apply it, wearing upper dentures, chewing gum, and brushing your teeth during the treatment day.

The most common side effects include:

headache and pain where Sitavig is applied.

These are not all the possible side effects of Sitavig. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also:

Sitavig side effects (in more detail)